Engineer II, Product

Getinge-posted 9 months ago
$80,000 - $105,000/Yr
Full-time • Mid Level
Remote • Merrimack, NH
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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.

  • 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.
  • 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.
  • Experience with Agile PLM and Minitab desired.
  • Knowledge of Good Documentation Practices (GDP) required.
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