Engineer II, Product

Location:

Merrimack, NH, US

Company:
Atrium Medical Corporation

Remote Work: 1-2 days at home (site based)

Salary Range: $90-110k, 8% STI

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life‑saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

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.

• 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.

• None

• Main contacts, internal:
  • Product 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

• 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 (