NPI Manufacturing Engineer, Senior

Forj Medical•Saint Paul, MN

19h•$100,000 - $130,000

About The Position

The Senior Manufacturing Engineer leads NPI for complex electro-mechanical medical devices across multiple product lines, working with development engineering early to design for manufacturability and guide transfer from pilot builds through sustaining handoff and full production ramp. This role also owns product build & delivery, documentation, cell layout, issue tracking and resolution, and continuous improvement, while coaching and mentoring the broader Manufacturing Engineering team.

Requirements

Bachelor's degree in engineering, technical, or scientific discipline
6+ years manufacturing engineering experience in an electronic-based manufacturing environment
Demonstrated experience leading new product introduction / design transfer for complex electromechanical devices
Demonstrated experience with regulated environments such as FDA QSRs and ISO 13485 for medical devices
Proficiency with quality improvement tools and techniques
Proficiency with writing and editing production and other technical documents
Strong interpersonal communication skills
Strong analytical skills and problem-solving ability
Ability to both work independently and function as a team member and ability to lead and drive cross-functional teams
Proficiency working with the Microsoft Office productivity suite
Must be authorized to work in the United States.

Nice To Haves

Master's degree in STEM field
Leadership experience in operations
Engineering experience with medical device manufacturing
Experience with DFM/DFA and production readiness reviews

Responsibilities

Partner closely with development engineering to coordinate and manage the smooth transfer of new products into production, from initial design reviews through production release.
Plan and execute pilot builds for new products, defining production cell layout, staffing, and equipment needs ahead of full-scale production.
Provide manufacturability (DFM/DFA) feedback to development engineering during design, and lead production readiness reviews to confirm processes, tooling, and documentation are qualified before ramp.
Coordinate with Production, Quality, and Supply Chain to plan and manage the ramp from production equivalent builds, pilot builds, into full production volume, tracking open issues to closure.
Create, update, and maintain core production documentation, including materials build documentation, assembly and test procedures, part drawings, and engineering change orders (ECOs).
Represent Manufacturing on cross-functional NPI core teams, providing design input, status updates, and flagging risks to program timelines and/or device cost.
Manage production builds across multiple product lines, actively maintaining the issues list and driving necessary device improvements and changes.
Serve as the primary point of contact to keep the production team aligned and informed on production status.
Work directly with customers as needed to support technical requests or specialized product needs.
Maintain up-to-date awareness of medical device requirements and stay current on existing and emerging manufacturing processes and trends.
Own and execute quality documentation requirements specific to the assigned product lines.
Partner directly with the Quality Engineering team to quickly address, troubleshoot, and resolve any quality issues or concerns that arise on the line.