Product Development Engineer III

Midwest Interventional Systems

Maple Grove, Minnesota

JOB DETAILS
SKILLS
Best Practices, Cross-Functional, Customer Relations, Documentation, Feasibility Analysis, ISO (International Organization for Standardization), Machine Tool, Maintain Compliance, Manufacturing Requirements, Manufacturing/Industrial Processes, Mentoring, Process Validation, Product Development, Product Engineering, Product Lifecycle, Quality Assurance Methodology, Risk Analysis, Risk Management, Strategic Planning, Technical Leadership, Technical Presentation, Technical Writing, Tolerance Analysis, Trade Studies, Validation Plan, Validation Testing, Verification Plans
LOCATION
Maple Grove, Minnesota
POSTED
30+ days ago

Description:

The Product Development Engineer III serves as a technical lead and independently drives major portions of the product development lifecycle from concept through commercialization. This role leads complex design activities, oversees verification and validation strategies, performs advanced risk management, and contributes to cross-functional planning. The Engineer III mentors junior engineers, leads technical workstreams, and ensures compliance with QMSR, ISO 13485:2016, and ISO 14971.

 

Duties and Responsibilities:

  • Lead development of complex components, assemblies, and processes; establish design strategy within assigned workstreams.
  • Own design transfer activities including manufacturing collaboration, process validation input, and technical documentation.
  • Architect and validate advanced test methods; design complex fixtures and tooling.
  • Lead verification and validation planning and execution; synthesize data and produce high-quality technical reports.
  • Conduct feasibility evaluations, risk analyses, tolerance assessments, and system-level trade studies.
  • Serve as a primary technical contributor in cross-functional reviews with Quality, Regulatory, Manufacturing, and suppliers.
  • Present technical findings to customers; lead portions of client interactions and planning discussions.
  • Maintain accurate and compliant documentation throughout all development phases.
  • Mentor and coach junior and mid-level engineers; provide feedback and guide engineering best practices.
 

About the Company

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Midwest Interventional Systems