Engineer II, Product Position Available In Hillsborough, New Hampshire

Engineer II, Product

Date:

Apr 3, 2025

Location:

Merrimack, NH, US

Company:

Atrium Medical Corporation

Remote Work:

0 days at home (site based)

Salary Range:

80,000 – 105,000 annual + 8 % STIP
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.
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.

Supervision/Management Of Others:

None
Internal and External Contacts/Relationships
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
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 (