Engineer II, Product

Getinge • Merrimack, NH

317d • $80,000 - $105,000 • Remote

About The Position

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.

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.

Nice To Haves

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

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Wholesale Trade Agents and Brokers
• Education Level: Bachelor's degree