Senior NPI Manufacturing Engineer - Medical Devices

Forj Medical

Saint Paul (MN)

On-site

USD 110,000 - 150,000

Full time

2 days ago

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Benefits offered by this job

Health insurance

401K

Time off programs

Annual bonus potential

Job summary

Forj Medical is seeking a Senior Manufacturing Engineer to lead NPI for complex electro-mechanical medical devices. You will work with development engineering early to ensure design for manufacturability and guide transfers from pilot builds through full production ramp.

You will own build documentation, cell layout, issue tracking, and continuous improvement while mentoring the Manufacturing Engineering team.

Qualifications

Education: Bachelor's degree in engineering, technical, or scientific discipline.
Experience: 6+ years manufacturing engineering experience in an electronic-based environment.
NPI: Demonstrated experience leading new product introduction / design transfer for complex electromechanical devices.
Regulatory: Experience with FDA QSRs and ISO 13485 for medical devices.
Quality tools: Proficiency with quality improvement tools and techniques.
Technical writing: Proficiency with writing and editing production and other technical documents.
Communication: Strong interpersonal communication skills.
Problem solving: Strong analytical and problem-solving ability.
Team leadership: Ability to lead cross-functional teams.
Software: Proficiency with Microsoft Office.

Responsibilities

New product transfer: Coordinate smooth transfer of new products into production.
Pilot build leadership: Plan pilot builds and define cell layout and staffing.
Production readiness & DFM: Provide manufacturability feedback and readiness reviews.
Ramp-up planning: Coordinate ramp from pilot builds to full production.
Documentation lifecycle: Create and maintain core production docs and ECOs.
NPI representation: Represent Manufacturing on cross-functional NPI teams.
Production line management: Manage production across multiple product lines.
Team communication: Keep production team aligned on status.
Customer interface: Support technical requests or specialized needs.
CI & technical awareness: Stay current on manufacturing trends.
Quality integration: Work with Quality to address issues on the line.