Assembler Marking Devices Job Description Samples

Results for the star of Assembler Marking Devices

Medical Device Assembler

Great Company! - Catheter Assembler- San Carlos- Long Term Assignment
We are really looking for someone with small catheter experience (at least 5 years) emphasizing skiving/hole cutting/razor blade abilities.
  • 40 hours per week day shift.
  • Will work with engineers and R&D to help with initial build for small start-up company.
  • Must be proficient working under a microscope.
  • Performs fabrication of pacing lead sub-assemblies and final lead assembly per established Manufacturing Process Instructions. Adheres to established company timelines for all product builds.
IV. GENERAL DUTIES AND RESPONSIBILITIES:
  • Perform strict adherence to established Manufacturing Process Instructions. Recording of accurate information into the Lot History Record for all product builds.
  • Provide open communications and feedback to both Operations Director and V.P. of R&D related to progress of all product builds, and any issues that may affect the quality and/or progress of each product build, consistent with the company timeline.
  • Identify manufacturing and/or process challenges to improve fabrication techniques, quality or efficiency of product builds.
  • Adhere to BioTrace Medical's Quality Policy and Good Manufacturing Practices.
  • Support company goals and objectives, policies and procedures, the QSR, and other FDA/MDD regulations.
V. SPECIFIC COMPETANCIES
  • Demonstrated manual proficiency working under a microscope (10x-30x) to prepare and assemble complex and precision catheter components and sub-assemblies, and final catheter assembly at the scale of a 6F catheter (0.080 catheter diameter) or smaller. Relevant experience :
    • Assembly of intravascular guide wires;
    • (0.014 and/or 0.035 )
    • Assembly of PTCA or PTA catheters
    • Assembly of atherectomy catheters
  • Demonstrated examples of working with the following tools and processes under a microscope (10x-30x):
    • Micro-crimpers and crimping operations
    • UV-bonding adhesives and UV light source
    • Hypotube hole cutters
    • Assembly of micro-subassemblies into the scale of a 6F catheter system
    • Preparation of micro-hypotubes for assembly into the final catheter (holding & cutting to length using pin vices)
  • Experience using
    • Dremel tools
    • Analog calipers
VI. EDUCATION REQUIREMENTS:
High school diploma required.
VII. EXPERIENCE REQUIREMENTS:
Minimum 5 years medical device industry experience in the fabrication of micro-catheters preferable.
Some experience in Research and Development desirable.
VIII. OTHER QUALIFICATIONS:
  • Working knowledge of GMP (Good Manufacturing Practices) and cleanroom protocol.
  • Excellent manual dexterity.
  • Flexibility with respect to work hours as some evening/weekend work may be required.
  • Proficient spoken and written English.

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OR Charge/Preceptor RN – Meridian Mark - Days

Position:  Perioperative Charge/Preceptor RN – Days

Location:
  Atlanta, GA
Salary:  $25 - $47.00/hour
Benefits:  Yes
Relocation Assistance:  Yes

Position Type:
  Full-time
Facility Type:   6-Bed, Outpatient Surgical Center
Shift:  Days
Weekends:  No
Call:  No
Experience:

  • Two (2) years recent experience in specialty.
  • Completion of the Charge Preceptor course at our facility.
  • Demonstrated proficiency in skills applicable to designated area within probationary period.
  • Demonstrated ability to assume Charge Nurse responsibilities and clinical expertise in area.
  • Successful completion of a management course prior to appointment, or within six (6) months of employment.
Education:
  • Graduate from an accredited school of nursing
Licensure &
Certifications Required:
  • Active RN License, unencumbered
  • BLS
  • ACLS
  • National Certification, CNOR, preferred
  • Member of professional organization, AORN, ASORN, ASPAN, etc. Preferred

Job Description:
  • The Charge Preceptor RN will be responsible for coordinating daily activities and distribution of work in area during scheduled shift;
  • As a Preceptor Nurse, acts as a professional educator and resource for new employees, demonstrating clinical expertise and competence.
  • The approximate amount of overall participation in direct patient care activities is 80% and Charge Preceptor duties is 20%.
  • The range of roles between Charge and Preceptor may vary dependent upon patient acuity and volume issues.
  • Works with a unit specific patient population.
  • Care and/or services will be provided to pediatric, adolescent, adult, and geriatric patients.
  • This position is required to set priorities based on the situation at hand, and is a combination of direct patient care, management (charge), and education (preceptor) roles with responsibility for a unit during an eight (8) to twelve (12) hour shift.
Facility
Overview:
  • Our Hospitals have been voted "Atlanta's Most Preferred Hospital for All Health Care Needs" for more than 16 years.
  • Forbes Top 25 Employer in the US!
Service Area
Overview:
  • As a leader in surgical services, specializing in Robotic, General, Bariatric, Neuro, Orthopedic, Breast, Plastic, and Gynecologic Surgery, we understand the importance of investing in state-of-the-art technology.
  • We perform more than 40,500 cases annually, 27,000 at the Atlanta campus – the most of any single hospital in Georgia. 
  • We are home to many of Atlanta’s finest surgeons, in a variety of specialties, and offer the latest technology available in healthcare today. 
  • We offer our patients innovative technology, including: daVinci® robotic surgical system, O-arm Intraoperative Imaging, HD technology, Ci™ System - computer-assisted orthopedic surgery system, artificial spinal disc, and stealth-guided image navigation. 
  • New advances in surgical technology allow us to stay at the forefront of medicine and devote more time to providing the best patient care possible. 
  • Many of the surgeons on staff are pioneers in laparoscopic surgery and are nationally recognized for their expertise in this area and many other minimally invasive techniques.

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Sales Associate In Marked Tree, AR

At Dollar General, our customer is at the center of everything we do! We are a fast-moving Fortune 200 publicly-traded company with more than 13,000 stores and 14 distribution centers in 44 states, growing by hundreds of stores each year. We work in an energetic atmosphere that embraces innovation and teamwork. At Dollar General, you can see a clear and fast path to career growth and success. We are committed to attracting talented and motivated people who can advance our mission of "Serving Others." Let's Grow Together! GENERAL SUMMARY: Act as the point of contact for customers. Assist in setting and maintaining plan-o-grams and programs. Stock merchandise adequately. Perform other duties as necessary to maximize profitability, customer satisfaction, and teamwork, while protecting company assets. DUTIES and ESSENTIAL JOB FUNCTIONS: + Unload trucks.

  • Follow company work processes to receive, open and unpack cartons and totes; store merchandise in stock room or move directly to sales floor.

  • Build merchandise displays.

  • Stock merchandise; rotate and face merchandise on shelves.

  • Restock recovered merchandise.

  • Assist customers by locating merchandise.

  • Bail cardboard and take out trash; dust and mop store floors; clean restroom and stockroom.

  • Comply with company policies and procedures.

  • Greet customers.

  • Operate cash register and flatbed scanner to itemize and total customer's purchase; bag merchandise.

  • Collect payment from customer and make change.

  • Assist with ordering merchandise using hand-held scanners, as needed.

  • Clean front end of store and help set up sidewalk displays when necessary. KNOWLEDGE and SKILLS: + Effective interpersonal and oral communication skills.

  • Understanding of safety policies and practices.

  • Ability to read and follow plan-o-gram and merchandise presentation guidance.

  • Knowledge of basic cash handling procedures.

  • Basic mathematical skills.

  • Ability to perform IBM cash register functions. WORK EXPERIENCE and/or EDUCATION: + High school diploma or equivalent preferred.

  • Relocation assistance is not available for this position. Dollar General Corporation is an equal opportunity employer. Requisition ID: 2016-73651 Street: 212 HESTER PARKER DR External Company URL: http://www.dollargeneral.com

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Service Mark Service Technician - Propane

AmeriGas Propane is the nation's largest propane distributor, serving over 2 million residential, commercial, industrial, agricultural and motor fuel propane customers in all 50 states. AmeriGas is listed on the New York stock exchange [NYSE: APU]. For more information visit our website at www.amerigas.com Job Summary: With a commitment to safety; installs, maintains, and services all customer and company propane installations and equipment while providing excellent customer service. Works to meet location productivity and sales goals. Core Competencies: + Safety Mindset

  • Demonstrates an understanding of the importance of safety to the company; considers the impact on safety when making decisions; consistently models safety practices + Customer Focus

  • Makes customers the highest priority, second only to safety; is committed to meeting the needs of all customers; establishes rapport and engages customers in discussion of their needs; + Integrity & Trustworthiness

  • Demonstrates high professional and personal standards; treats people fairly and with respect; handles confidential information appropriately.

  • Communication
  • Listens and responds appropriately to others; articulates ideas clearly, persuasively, and concisely + Meets Commitments

  • Sees issues through to completion; checks with appropriate parties to ensure issues have been completely resolved; finds ways to overcome barriers that initially prevents oneself from immediately solving problems and getting the job done.

  • Problem Solving
  • Effectively analyzes and draws conclusions from information in a thorough but timely manner; identifies work-related problems; analyzes problems in a systematic but timely manner to identify root cause, and acts decisively to implement solutions and resolve crises. Duties and Responsibilities: + Drives a flatbed truck with a crane and boom attached to deliver, install, and remove tanks of various sizes at customer locations + Complete field repairs of tank valves and seals; finds and repairs leaks at customer sites + Deliver and pick up customer storage cages; repair storage cages as needed + Performs all daily functions in a safe manner by adhering to all federal and state codes and regulations, in addition to all AmeriGas Safety and Operations Policies and Procedures; utilizing all Personal Protective Equipment; + Proactively identifies and reports safety concerns and violations at the plant or customer sites + Consistently handles safety issues in a calm manner and uses knowledge of safety procedures to arrive at an effective resolution
  • Maintain service vehicle by reviewing maintenance record, perform pre- and post-trip inspections. Secure truck and equipment consistent with security policy

  • Maintains excellent customer relations by providing courteous, professional and timely service while limiting customer call backs + Resolves customer issues and concerns in cooperation with other location employees to gain customer loyalty and increase the customer base through customer growth and retention.

  • Offers timely, thorough explanations of current service and makes recommendations for customers + Proactively provides customers with status reports and progress updates without being asked; reviews what work has been done in a way that helps justify and explain the cost of service + Proactively follows up with co-workers and customers after service is complete to ensure all commitments have been met + Promotes location growth by responding to direct sales inquiries from potential customers + Communicates and distributes location specials and marketing programs to customers and promotes the use of additional propane gas appliances.

  • Generates income for the location by accurately recording materials and labor utilized in service calls and installations

  • Maintains inventory controls and completing appropriate paperwork for all work completed.

  • Assist in the delivery of propane as required by location manager.

  • Installs and services customer and company installations by utilizing mechanical skills to examine equipment Knowledge, Skills and Abilities: + DOT licensing; CDL with HazMat, tanker, and air brakes endorsement; + CETP training + Any state and local licenses required.

  • Must be able to work well in a team-oriented environment.

  • Must be service-oriented and sales minded.

  • Must be resourceful and excel at problem resolution. Education and Experience Required: + High school diploma required, college degree preferred + Two to five years related experience, in the propane industry preferred Working conditions: + Environmental conditions such as rain, mud, ice, snow, and uneven terrain may affect this job, as the employee spends most of the workday outdoors. AmeriGas is a Drug Free Workplace. Candidates must be able to pass a pre-employment drug screen and a criminal background check. EOE: AA/M/F/Disabled/Veteran Requisition ID: 6372

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Road And Bridge Supervisor - Signs And Markings

Description Arapahoe County

  • Colorado's First in so many ways! Arapahoe County is seeking a Road and Road and Bridge Supervisor

  • Signs and Markings for our Eastern Service Center in Bennett, Colorado. This position performs a variety of skilled and semi-skilled duties associated with the supervision of assigned crew.

    The duties will include the supervision of four full time employees responsible for maintaining all of the signs and markings within the County to include: long line striping, durable markings, sign design, fabrication, and install. This position will also supervise four full time employees that are responsible for Right of Way maintenance work including: mowing, guardrail, snow fence, tree trimming, and minor bridge repairs. Arapahoe County offers a competitive, comprehensive benefits package!

    Please visit our webpage to learn more! http://www.co.arapahoe.co.us/index.aspx?NID=384 The anticipated hiring salary range is $29.01 - $30.50/ hour. Duties The following duty statements are illustrative of the essential functions of the job and do not include other non-essential or marginal duties that may be required. The County reserves the right to modify or change the duties or essential functions of the job at any time.

    Maintains supervisory responsibility for the maintenance, repair, and construction of the County's assets that are within the County ROW roads and assets; inspects assigned assets to determine deficiencies and maintenance needs; provides input into annual work plan for county roads; assists in establishing maintenance priorities and schedules as required to maintain County's assets on a daily and seasonal basis; assists in determining work methods and procedures required to maintain specific assets. Supervises assigned crew in daily work assignments which includes giving daily work assignments, being responsible for jobsite traffic control, performing the role of the Traffic Control Supervisor, acquiring utility locates, ensuring safety rules are followed, and monitoring project performance and ensuring repair, maintenance, and construction work is completed in accordance with specifications. Trains crew on correct work and safety methods.

    Participates in the development and implementation of goals, objectives, policies and priorities; recommends and implements resulting policies and procedures. Assists in the hiring of personnel which includes interviewing, making recommendations and selection. Provides supervision which includes completion of annual performance reviews, setting performance goals for employees; providing input for Operation Section's salary calibration, writing and delivering verbal and written corrective actions; training and developing employees in areas of work processes and safety; and ensuring compliance with all approved County guidelines such as personnel guidelines.

    Accepts responsibility as the Lead Supervisor during emergency response activities to include coordination of emergency response efforts and deployment of resources for the mitigation of threats, man-made or natural, to the road network system. Remains on-call during non-working hours to receive reports of road hazards and snow removal on a scheduled basis. Works winter storm duty and other emergency conditions at all hours of the day or night.

    Operates trucks and/or heavy equipment during emergency or manpower shortage situations to accomplish tasks. May perform duties of the Operations Manager (OM) during OM's scheduled absences to include scheduling of resources, coordination of work programs, and interaction between east and west jurisdictions. Ensures that equipment assigned to crew is being maintained according to the manufacturers' guidelines and that vehicle maintenance issues are reported to the Fleet Department in a timely manner.

    Coordinates vehicle repairs with the Fleet Department and vendors if necessary. Properly disposes of unused material according to standard operating procedure. Assists in developing or modifying standard operating procedures as needed for areas of responsibility.

    May perform calculations of asphalt or other material needs, and orders necessary materials, under the direction of Operations Manager or Road and Bridge Division Manager. Performs daily work input into Accela Automation in a timely and accurate manner to include accomplishments, materials, and equipment usage. Responds to accidents of assigned personnel and completes accident reports.

    Responds to Service Requests within 48 hours of being assigned the Service Request by a written response in Accela. Performs survey work to check grades for drainage and construction projects. Interacts with the general public about Service Requests.

    Maintains timesheet records on assigned personnel. Works on schedules with Operations Manager and Division Manager. Performs other duties as assigned.

    Requirements SKILLS AND ABILITIES: Knowledge of road construction, design, material, repair and maintenance procedures and techniques. Knowledge of MUTCD standards.

    Knowledge of safety rules, regulations, and practices. Ability to read and interpret maps, engineering drawings and blueprints relative to road and bridge construction, maintenance and repair. Familiarity with the operation of heavy highway construction and maintenance equipment, such as laydown machine, snow plow and sander, highway striping machine, graders, front end loader, trucks including tractor and low boy trailers, backhoe, and bulldozer.

    Ability to perform strenuous manual labor as required. Ability to coordinate and supervise personnel and equipment physically spread over a large geographical area. Ability to communicate effectively, both orally and in writing, with contractors, supervisors, other employees, and the general public.

    Ability to establish and maintain effective working relationships with supervisors, subordinates, and other employees. Knowledge and usage of basic computer skills, survey skills and engineering techniques. Ability to ascertain and practice the discipline of project management.

    Ability to perform the duties of a Traffic Control Supervisor (TCS) as defined by industry standards.

    Knowledge of Cardio Pulmonary Resuscitation (CPR) and first aid. BEHAVIORAL COMPETENCIES:

    Action Oriented: Enjoys working hard; is action oriented and full of energy for the things he/she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities than others. Timely Decision Making:

    Makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick decision. Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions.

    Delegation: Clearly and comfortably delegates both routine and important tasks and decisions; broadly shares both responsibility and accountability; tends to trust people to perform; lets direct reports and others finish their own work. Integrity and Trust: Is widely trusted; is seen as a direct, truthful individual; can present the unvarnished truth in an appropriate and helpful manner; keeps confidences; admits mistakes; doesn't misrepresent him/herself for personal gain.

    Managerial Courage: Doesn't hold back anything that needs to be said; provides current, direct, complete, and "actionable" positive and corrective feedback to others; lets people know where they stand; faces up to people problems on any person or situation (not including direct reports quickly and directly; is not afraid to take negative action when necessary. Managing and Measuring Work:

    Clearly assigns responsibility for tasks and decisions; sets clear objectives and measures; monitors process, progress, and results; designs feedback loops into work. Organizing: Can marshal resources (people, funding, material, support) to get things done; can orchestrate multiple activities at once to accomplish a goal; uses resources effectively and efficiently; arranges information and files in a useful manner. EDUCATION: High school graduation or GED equivalent with two (2) years of training or technical school on the principals of engineering, construction management or related course work.

    EXPERIENCE: Five (5) years experience with heavy highway equipment, construction and maintenance. Minimum of three (3) years experience operating heavy equipment or equipment associated with signs and markings maintenance. At least one (1) year of experience as a supervisor managing construction or maintenance crews. (An equivalent combination of education and work experience that satisfy the requirements of the job may be sufficient). Supplemental Information This position requires successful completion of pre-employment background and motor vehicle checks.

    Must be able to pass the Federal Department of Transportation (DOT) Federal Motor Carrier Safety Administration (FMCSA) required Drug and Alcohol and Physical examinations and a physical capabilities examination prior to hire. This position is required to work on an on-call basis for winter storm duty and other emergency conditions at all hours of the day or night. Shift work for snowstorms may require 16 hour shifts or longer based on the severity of the storm. NECESSARY SPECIAL REQUIREMENTS:

    Possession of a Colorado CDL Class "A" license with tanker endorsement or the ability to obtain within one year. ATTSA certified Traffic Control Supervisor or the ability to obtain within one year. SUPERVISION RECEIVED: Works under the general direction of the Road and Bridge Operations Manager. SUPERVISION EXERCISED:

    Provides direct supervision over assigned personnel such as Heavy Equipment Operator, Light Equipment Operator, Utility Worker, Senior Signs and Marking's Technician. INTERPERSONAL CONTACTS: Contacts are with supervisors, management, peers, subordinates, elected officials, customers, and/or vendors. Contacts require the ability to exercise a high degree of interpersonal skills to influence persons at all levels.

    Incumbent is accountable for the results of the contact. WORK ENVIRONMENT: Work area is within the Arapahoe County Maintenance Shop and involves some exposure to fumes, noise, and smoke. In the field, position may be exposed to all weather conditions and the hazards of working near vehicular traffic. PHYSICAL DEMANDS: *The following are some of the physical demands commonly associated with this position.

  • Spends 50% of the time sitting and 50% of the time either standing or walking. Occasionally lifts, carries, pulls or pushes up to 50 lbs.

    Uses cart, dolly, or other equipment to carry in excess of 50 lbs. Occasionally stoops, kneels, balances, reaches, crawls and crouches while performing office or work duties. Verbal and auditory capacity enabling interpersonal communication through automated devices, such as telephones, radios, etc.

    Constant use of eye, hand and finger coordination enabling the use of automated office machinery or equipment. Visual capacity enabling constant use of computer or other work related equipment.Definitions: Occasionally: Activity exists less than 1/3 of the time.

    Frequently: Activity exists between 1/3 and 2/3 of the time. Constantly: Activity exists more than 2/3 of the time.

Salary: $50,835.20 - $76,606.41 Annually Location: 80102, CO Job Type: Full-time Job Number: 02972 Department: Public Works and Development Closing: 5/28/2017 11:59 PM Mountain Agency: Arapahoe County Address: 5334 S. Prince Street Littleton, Colorado, 80120. Phone: (303) 636-1729 Website: http://agency.governmentjobs.com/arapahoe/default.cfm



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Stock & Mark Associate

Stock & Mark Associate Work LocationCamp Hill Mall Store Address370 Camp Hill Mall, 32nd & Trindle Rd, Camp Hill, PA. 17011 Schedule StatusNone Apply Now Boscov’s Retail Stock & Mark Associate Job Description Use your stock background to launch an exciting career in retail with one of the nation’s leading retailers! Boscov's is a chain of full service department stores serving the total family needs of our customers. For nearly 100 years, Boscov's has been known for its great values and famous brands, and for offering a broad selection of quality merchandise in its stores and online. We are looking for Retail Stock & Mark Associates to join our growing retail team. As part of a fast-paced, dynamic stock team, you will develop relationships with our coworkers and ensure that each customer’s needs are met in a quick and efficient manner. Whether you have previous stock experience OR customer service experience, this is a great opportunity to pursue a rewarding career with a company known for quality and big savings. Apply today! Job Responsibilities As a Retail Stock & Mark Associate, you will ensure the timely delivery of goods to the selling floor. You will be responsible for establishing professional, yet personalized rapport with each customer in order to provide the best customer experience. Additional responsibilities include: + Expedite the preparation and transfer of merchandise to selling departments on a timely basis.

  • Open and unpack cartons or bins, place clothing on hangers, strip plastic, price tickets and/or sensamatic tags.

  • Check invoices

  • Assist with stocking and reticketing of merchandise on the selling floor.

  • Process direct shipments and Internet orders.

  • Make signs and tickets.

  • Assist customers, provide customer service and sell merchandise as business dictates. Job Requirements Successful candidates for the Retail Stock & Mark Associate role should have the ability and desire to actively engage customers and provide excellent customer service. Additional requirements of the Retail Stock & Mark Associate include: + Enjoys working with customers, is stock/sales directed and committed to excellentcustomer service.

  • Prior stock and or selling experience preferred.

  • Communicate verbally and via telephone with coworkers, supervisor, department managers and Management.

  • Possess basic math skills.

  • Computer literate, ability to use a telxon, and safely operate a freight elevator. Benefits At Boscov’s, we value our employees, and that’s why we provide a competitive compensation and benefits package. As a member of our retail operations team, you will be eligible to receive: + Competitive starting rate + Weekly Pay + Comprehensive benefits package, including medical/dental + Paid Vacations and Personal days + Liberal Employee Discounts + Opportunity for Advancement + Much More! Work where people love to shop! Applications for this position are accepted in-store only. Completion of our Job Interest Form isNOTan application for employment. Equal Opportunity Employer

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Medical Device Assembler

We are a high-tech manufacturing company located in San Jose, and have been doing business for over 15 years in Silicon Valley. As a Medical Device Manufacturer, we are looking for an experienced assemblers to join our company.

You will enjoy working in a very clean, high tech, professional environment together with inspirational co-workers. Positions are expected to be long term with excellent opportunities for growth and advancement. Responsibilities including, but not limited to:The primary responsibility will be to support all projects.Follow detailed assembly instructions, processes and procedures per order requirements.Comply with company policies, guidelines and regulatory requirements.Report problems with quality, processes, equipment and materials.Report errors and make corrections.Maintain a safe, clean, and organized work environment. Knowledge and Skill requirements

Able to read and comprehend blueprints written in English.Able to understand and speak English and interpret instructions.Able to use proven techniques that meet or exceed industry standards.Able to perform continuity check and communication with all level of staffs.Possess strong organizational skills; attention to detail.



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Assemblers - Medical Devices

Assembler  Swing Shift  (2:00PM -11:00PM)
Description
POSITION SUMMARY
This position is responsible for following applicable procedures to build complex medical devices under minimal direction and supervision.  Participates as a team member generating and maintaining complete documentation necessary for assigned project tasks.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Responsibilities will include:

  • Assembly of subassemblies and final assemblies in accordance with GMP.
  • Identifying and reporting any product quality problems.
  • Controlling further processing of non-conforming product until the deficiency or unsatisfactory condition has been corrected.
  • Initiating and recommending action to prevent the occurrence of product nonconformi¬ty.
  • Initiating, recommending, or providing solutions for problems as they arise. Assist with and verify the implementation of solutions.
    QUALIFICATIONS
  • Maintenance of device history records
  • Reporting out of specification conditions to supervisor
  • Following Good Manufacturing Practices
  • Performing testing and recording data per written procedures and verbal instructions
  • Must be able to follow established policies and procedures and comply with regulatory requirements
  • Must be a positive, energetic team player, and an advocate for product excellence and quality.
  • Must be hands-on, results-oriented, who is a strong team player, excellent communicator, and comfortable in an entrepreneurial environment
  • Must be flexible and adaptable in a fast-paced, start-up environment
  • Must work well with others and be a team player
  • Must possess a “can-do” attitude
  • Must have the ability and desire to be proactive not just reactive; a questioning mindset
  • Overtime hours as needed
    EDUCATION AND EXPERIENCE
  • High school diploma required
  • Basic math skills required
  • 3+ years of related experience required
    Assembler,  
  • Swing Shift (2:00PM-11:00 PM)

    Description

    POSITION SUMMARY

    This position is responsible for following applicable procedures to build complex medical devices under minimal direction and supervision.  Participates as a team member generating and maintaining complete documentation necessary for assigned project tasks.

    ESSENTIAL DUTIES AND RESPONSIBILITIES

    Responsibilities will include:

    • Assembly of subassemblies and final assemblies in accordance with GMP.
    • Identifying and reporting any product quality problems.
    • Controlling further processing of non-conforming product until the deficiency or unsatisfactory condition has been corrected.
    • Initiating and recommending action to prevent the occurrence of product nonconformi­ty.
    • Initiating, recommending, or providing solutions for problems as they arise. Assist with and verify the implementation of solutions.

    QUALIFICATIONS

    • Maintenance of device history records
    • Reporting out of specification conditions to supervisor
    • Following Good Manufacturing Practices
    • Performing testing and recording data per written procedures and verbal instructions
    • Must be able to follow established policies and procedures and comply with regulatory requirements
    • Must be a positive, energetic team player, and an advocate for product excellence and quality.
    • Must be hands-on, results-oriented, who is a strong team player, excellent communicator, and comfortable in an entrepreneurial environment
    • Must be flexible and adaptable in a fast-paced, start-up environment
    • Must work well with others and be a team player
    • Must possess a “can-do" attitude
    • Must have the ability and desire to be proactive not just reactive; a questioning mindset
    • Overtime hours as needed

    EDUCATION AND EXPERIENCE

    • High school diploma required
    • Basic math skills required
    • 3+ years of related experience required

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    Security Analyst, Devices

    Mobile Device Security Analyst to work directly with mission support program for the Office of Cybersecurity’s Information Security Directorate (INFOSEC).  The overall scope of this work is to support INFOSEC with Information Technology (IT) support services including protection of networks against unauthorized access, modification of data, and malicious activity.  Support the continuous management and monitoring of networks and analyze and respond to alerts as they occur.  

    Responsibilities:
    Provide expert cybersecurity knowledge of enterprise mobility systems to business and technology teams and facilitates the collaborative development of the security of the mobile technology strategy, standards, roadmaps, and practices.
    Determine the most efficient methodology and path for securing the mobile infrastructure to include assessing technical configurations and security settings for mobile devices.
    Determine the most efficient methodology and path for analyzing and mitigating mobile incidents.
    Assist in the development of a mobile incident response process.
    Understand threats to mobile ecosystems and have the ability to design security solutions in support of mobile environments.
    Assess and integrate iOs, Android phones, and tablets within an integrated mobile threat platform (MTP) and mobile device management (MDM) environment.
    Review applications and provide a recommendation on whether or not applications should be approved for use on the mobile platform.
    Assess security risks for integrating enterprise and commercial mobile apps into the mobile environment.
    Evaluate, recommend, and support operational changes, enhancements, and modifications to securing the mobile environment.
    Develop, maintain, and support operational documentation to include, but not limited to Standard Operations Procedures (SOPs), requirements documents, back-up/contingency plans, architectural design documents, and diagrams, and/or Information Assurance (IA) related documentation.
    Perform other official duties as assigned.
    Minimum Qualifications and
    Requirements:
    Bachelor’s degree in the computer related field plus 5 years of professional experience or equivalent work experience.
    Demonstrated experience and advanced knowledge of security systems analysis, testing, and documentation.
    Knowledge of virtual environments, network operating systems, mobile device environments, and data encryption methods.
    Demonstrated expertise in communication protocols, network operating systems, servers, firewall implementation, IPS/IDS systems, and advanced malware detection systems.
    Unless otherwise stated, a minimum of a Secret security clearance preferred.
    Ability to maintain effective working relationships with colleagues, users, contractors, and vendors.
    Prefer one or more of the following certifications: Security + CE; GICSP; GSEC; SSCP; CISSP; CEH; CASP CE; GCIA; or GCIH.

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    Medical Device Regulatory Affairs Expert

    Medical Device Regulatory Affairs Expert

    Global Consulting Company

    Raynham, Mass. Location

    Green Card holders or US Citizens ONLY

    Do not apply unless you are a Green Card holder or a US Citizen

    MUST HAVE:  A minimum of 10 years of experience in Medical device Regulatory Affairs

    Biomedical Engineer / Science Degree


    Requirements:

  •     Biomedical Engineer / Science graduate with minimum of 10 years of experience in Medical device Regulatory Affairs
    Ability to work with cross-functional team members including R&D, Quality, Labeling, Sterility, Medical and Clinical.
  •     Experience in working with PLM systems.
    Experience in working with design controls.
  •     Strong proficiency in Microsoft Office including Word and Excel.
    Excellent written and oral communication skills.
  •     Languages: English required, German a plus.
    Ability to manage multiple tasks and be detail-oriented.
  •     Knowledge of EU Medical Device regulations and guidance documents as well as relevant standards (93/42/EEC, ISO 13485: 2016 etc.).
    Knowledge of US FDA regulations related to Medical Devices (21 CFR 820).
  •     RAC certification preferred.
  • Scope of Work
    Assist in the creation of technical documentation (technical files and design dossiers) for the customer’s Spine business that will meet the requirements of the new Medical Device Regulation (MDR) in the European Union.


    Responsibilities:

    Identify reference documents for technical documentation including, but not limited to, risk documents, validation documents and labeling.

  •     Identify policies, procedures and work instructions which support technical documentation activities. 
    Provide support for Clinical Evaluation Reports including references to required documentation.
  •     Prepare technical documentation for submission to Notified Bodies, as required.
    Prepare 510(k) dossier, PMA Supplements and Annual Reports
    Review change orders (design change, process change, labeling change etc.) and perform impact assessment on regulatory submission status.
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