NPI Manufacturing Engineer, Senior

Minnetronix Medical, Inc.; Saint Paul (MN); On-site; USD 105,000 - 150,000; Full time

Job summary

Minnetronix Medical, Inc. is seeking a Senior Manufacturing Engineer to lead NPI for complex electro-mechanical medical devices across multiple product lines.

You will collaborate with development engineering to design for manufacturability, guide transfers from pilot builds through ramp, own documentation, cell layout, and issue resolution, and mentor the Manufacturing Engineering team. The role emphasizes production readiness, ramp planning, and continuous improvement, with direct interaction

Qualifications

• 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.
• 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 and problem-solving ability.
• Ability to lead and drive cross-functional teams.
• Proficiency with Microsoft Office.

Responsibilities

• Coordinate and manage smooth transfer of new products into production from initial design reviews through production release.
• Plan and execute pilot builds, define production cell layout, staffing, and equipment needs.
• Provide manufacturability feedback to design and lead production readiness reviews.
• Coordinate ramp from pilot builds to full production volume and track open issues.
• Create, update, and maintain core production documentation including ECOs.
• Represent Manufacturing on cross-functional NPI core teams with status updates and risk flags.
• Manage production builds across product lines and drive improvements.
• Serve as primary contact to keep production team informed on status.
• Collaborate with customers on technical requests as needed.
• Maintain awareness of medical device manufacturing trends and CI opportunities.
• Own and execute quality documentation requirements for assigned product lines.
• Partner with Quality Engineering to address quality issues promptly.

Skills

NPI leadership

Design transfer

Regulatory compliance

Problem solving

Communication

Team leadership

Documentation writing

Education

Bachelor's degree in engineering

Master's degree in STEM field

Tools

Microsoft 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