Senior NPI Manufacturing Engineer – Medical Devices

Minnetronix Medical, Inc.

Saint Paul (MN)

On-site

USD 105,000 - 150,000

Full time

13 days ago
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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

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

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