Merrimack, New Hampshire

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.

 

Job Responsibilities and Essential Duties

  • Participates in design change projects to improve product performance, reduce cost and enhance the manufacturability of commercially released medical devices.
  • Supports CAPAs, NCRs and Product Complaints by investigating and addressing potential product design issues as appropriate.
  • Participants 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.
  • Aids in the development and revision of part specifications and other design documentation.
  • Performs Out of Specification (OOS) investigation reports for test failures.
  • Supports Out of Tolerance (OOT) investigations for equipment calibration failures.
  • 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. 
  • One year of experience in a regulated industry is preferred.
  • 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.
  • Experience with Agile PLM and Minitab desired.
  • Knowledge of Good Documentation Practices (GDP) required.
  • Excellent verbal and written communication skills.

 

Supervision/Management of Others

  • None

 

Internal and External Contacts / Relationships

  • Main contacts, internal;
    • Product Sustaining Engineering group members
    • R&D Staff including New Product Development and Research Groups
    • Executive Management Staff
    • Operations Management and Staff
    • Supply Chain Management and Staff
    • Marketing Management and Staff
    • QA/RA Management and Staff
    • Finance Management and Staff
    • Sales Management and Staff
  • Main contacts, external;
    • Key Opinion Leaders
    • Surgeons/ SMEs
    • Customers
    • Suppliers
    • Third-Party Contractors and Service-Providers

 

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.

 

Permissions

Each organization shall establish the appropriate authority, and interrelation of all employees who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.

 

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. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world’s most desired medtech company.

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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