NPI Manufacturing Engineer, Senior

Minnetronix Medical; Saint Paul (MN); On-site; USD 95,000 - 140,000; Full time

Job summary

Minnetronix Medical seeks a Senior Manufacturing Engineer to lead NPI and design transfer for complex electro-mechanical medical devices across multiple product lines. You will collaborate 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 and delivery, documentation, cell layout, issue tracking, and continuous improvement, while coaching and mentoring the

Qualifications

• Bachelor's degree in engineering or scientific field
• 6+ years manufacturing engineering in electronics
• NPI / design transfer experience for complex electromechanical devices
• Experience with FDA QSRs and ISO 13485 for medical devices
• Proficiency with quality improvement tools
• Strong communication and problem-solving abilities
• Technical writing skills for production and regulatory docs
• Ability to lead cross-functional teams
• Proficiency with MS Office tools

Responsibilities

• Lead New Product Introduction and design transfer from development to production
• Plan and lead pilot builds including cell layout and staffing
• Provide DFM/DFA feedback during design and lead production readiness reviews
• Coordinate ramp from pilot to full production, tracking issues to closure
• Create and maintain core production documentation and ECOs
• Represent Manufacturing on cross-functional NPI teams and manage risk
• Manage production builds across product lines and drive improvements
• Maintain clear production status communication with teams and customers

Skills

Communication

Problem solving

Team leadership

Technical writing

Microsoft Office

Education

Bachelor's degree in engineering or scientific discipline

Master's degree in STEM

Tools

MS Office

Job description

Job Summary

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.

Key Responsibilities

New Product Introduction & Design Transfer

• New product transfer: Partner closely with development engineering to coordinate and manage the smooth transfer of new products into production, from initial design reviews through production release.
• Pilot build leadership: Plan and execute pilot builds for new products, defining production cell layout, staffing, and equipment needs ahead of full-scale production.
• Production readiness & DFM: 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.
• Ramp-up planning: 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.
• Documentation lifecycle: Create, update, and maintain core production documentation, including materials build documentation, assembly and test procedures, part drawings, and engineering change orders (ECOs).
• NPI representation: Represent Manufacturing on cross-functional NPI core teams, providing design input, status updates, and flagging risks to program timelines and/or device cost.

Production Management & Support

• Product line management: Manage production builds across multiple product lines, actively maintaining the issues list and driving necessary device improvements and changes.
• Team communication: Serve as the primary point of contact to keep the production team aligned and informed on production status.
• Customer interface: Work directly with customers as needed to support technical requests or specialized product needs.

Continuous Improvement (CI) & Technical Awareness

• Industry and process trends: Maintain up-to-date awareness of medical device requirements and stay current on existing and emerging manufacturing processes and trends.

Quality Integration & Compliance

• Quality documentation: Own and execute quality documentation requirements specific to the assigned product lines.
• Quality collaboration: Partner directly with the Quality Engineering team to quickly address, troubleshoot, and resolve any quality issues or concerns that arise on the line.

Qualifications

Required

• Education: Bachelor's degree in engineering, technical, or scientific discipline
• Experience: 6+ years manufacturing engineering experience in an electronic-based manufacturing environment
• NPI background: Demonstrated experience leading new product introduction / design transfer for complex electromechanical devices
• Regulatory: Demonstrated experience with regulated environments such as 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 skills and problem-solving ability
• Team leadership: Ability to both work independently and function as a team member and ability to lead and drive cross-functional teams
• Software: Proficiency working with the Microsoft Office productivity suite

Preferred

• Education: Master's degree in STEM field
• Leadership: Leadership experience in operations
• Industry: Engineering experience with medical device manufacturing
• Design collaboration: Experience with DFM/DFA and production readiness reviews