Merrimack, New Hampshire

This R&D Engineer, Product Sustaining is an active member of the Product Sustaining Engineering Team and provides support by maintaining the design of our existing commercially released medical devices. You will be part of a collaborative cross-functional team to support design and supplier-related changes, corrective and preventive actions (CAPAs), non-conformances (NCRs), product complaints, and other compliance projects for a class III balloon expandable covered stent. The engineer will generate and execute design verification testing, including aging and handling and distribution studies. This role is a balance between documentation and hands-on testing of the product.

 

Who You Are:

Someone with a background in design and compliance for medical devices and components. You have experience in design and process controls, assessment of design changes, review of and compliance to external standards and regulation.  Most likely you have some experience with test method development, product testing, and specification generation.   You possess some experience with Design Verification and Design Validation, and change control or have the ability to learn quickly. You enjoy being hands on in testing and redesigning medical devices. Demonstrated analytical, interpersonal, and technical writing skills for the generation of protocols and reports. 

 

You are an individual that is self-driven, possesses a strong desire to learn, strives for excellence, and always keeps quality and the customer in mind in everything you do.

 

Flexible work hours and options are available; however, the position is expected to have on-site responsibilities performing engineering studies and product testing.

 

 

Job Overview

This position delivers engineering solutions to sustain production of implantable and consumable medical devices. Responsibilities include working with cross-functional teams to support design and supplier changes, CAPAs, NCRs, Product Complaints and other compliance projects. This job requires knowledge of medical device regulations including design controls.

 

Job Responsibilities and Essential Duties

  • Initiates design change projects to improve product performance, reduce cost and enhance the manufacturability of commercially released medical devices.
  • Works with current suppliers on changes to existing purchased components and with new prospective suppliers.
  • Supports CAPAs, NCRs and Product Complaints by investigating and addressing potential product design issues as appropriate.
  • Participates in Design Reviews to evaluate adequacy of design requirements, assess the capability of the design to meet requirements and identify and resolve problems.
  • Works cross-functionally on design changes, process improvement projects and quality/compliance initiatives.
  • Creates and executes protocols for Design Verification and Validation activities, engineering studies and feasibility studies.
  • Aids in the selection, design and evaluation of process and test equipment.
  • Creates and executes protocols and reports for process validation, test method validation, equipment qualification and gage R&R studies.
  • Processes change orders to create or revise design input and output documentation.
  • Performs product testing and engineering studies to support design change and investigational activities.
  • Performs Out of Specification (OOS) investigation reports for test failures.
  • Supports Out of Tolerance (OOT) investigations for equipment calibration failures.
  • Supports the development and revision of part specifications and other design documentation.
  • Maintains the Design History File (DHF) and Device Master Record (DMR) throughout the lifecycle of the product based on changes to the product design or manufacturing process.
  • Periodically provides updates to project teams and program managers.
  • Contributes to the team effort by accomplishing related tasks as needed.

 

Minimum Requirements

  • Bachelor’s degree in Engineering or scientific discipline, such as chemical, biomedical, materials, or mechanical engineering. 
  • A minimum of two years’ experience in the medical device industry (or other regulated industry) with relevant experience in design controls, production and process controls and/or R&D or related areas.
  • Knowledge of 21 CFR Part 820 and standards relevant to medical devices.
  • Strong experience with Microsoft Office applications (Word/Excel/PowerPoint) is required.

 

Required Knowledge, Skills and Abilities

  • Demonstrated ability to solve technical challenges with cross-functional teams.
  • Strong analytical and problem solving skills.
  • Strong communication and collaboration skills.
  • Self-motivated with the ability to accomplish project goals with minimal supervision.
  • Experience with Agile PLM and Minitab desired.
  • Knowledge of Good Documentation Practices (GDP) required.
  • Excellent verbal and written communication skills.

 

Quality Requirements

  • Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
  • Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (as applicable to the job function).
  • Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (as applicable to your job function).
  • Attend all required Quality & Compliance training at the specified interval.
  • Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.

 

Environmental/Safety/Physical Work Conditions

  • Ensures environmental consciousness and safe practices are exhibited in decisions.
  • May work extended hours during peak business cycles.
  • This position may require some travel to supplier sites (<10%).

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.


We look forward to receiving your application.

Merrimack, New Hampshire

Getinge Infection Control

Getinge Infection Control (GETINGE) is one out of three business areas within Getinge AB, a publicly-listed, Swedish-based group of companies. The Getinge Infection Control business area consists of two divisions; Healthcare and Life Science. For the Healthcare sector, GETINGE provides solutions for infection control whereas for the Life Science sector, GETINGE is a key provider of solutions for contamination prevention.

Worldwide, GETINGE ranks among the leading providers of disinfectors and sterilizers within the healthcare and life sciences segments. Since its foundation in 1904, Getinge Infection Control has stood for innovation and technological progress in the field of disinfection and sterilization. Together with the other two business areas, Extended Care (ARJOHUNTLEIGH) and Medical Systems (MAQUET), the entire Getinge Group focuses on state-of-the-art medical technology.

The Getinge Infection Control organization is to be found all over the world, with 36 subsidiaries on six continents and over 230 distributors and partner companies in sales and service representing Getinge Infection Control.

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