Sr. Mechanical Engineer

Job Title:

Senior Mechanical Engineer (Medical Devices – Design & Sustaining Engineering)

Location:

[Lafayette, CO / Hybrid / Global]

Employment Type:

Fulltime

• Design & Development (Design Controls)
  • Lead mechanical design activities in compliance with Design Control requirements (21 CFR Part 820 / ISO 13485)
  • Develop and maintain design documentation including:
    • Design inputs/outputs
    • Verification & validation plans/reports (DV/PV)
    • Design reviews
    • Traceability matrices (DHF)
  • Ensure alignment with User Needs, Intended Use, and Risk Management outputs
• New Product Introduction (NPI)
  • Drive product development from concept through design transfer to manufacturing
  • Support prototype builds, design verification (DV), validation (PV), and clinical readiness
  • Collaborate with manufacturing and quality teams to ensure design for manufacturability (DFM) and scalability
  • Support process validation activities (IQ/OQ/PQ)
• Sustaining Engineering & Post-Market Support
  • Lead root cause investigations (RCA) for product complaints, CAPAs, and non-conformances
  • Implement design changes through controlled Engineering Change Orders (ECOs) with full traceability
  • Support post-market surveillance, field issue resolution, and regulatory reporting inputs
  • Ensure continuous compliance of released products
• Risk Management & Compliance
  • Lead and contribute to risk management activities per ISO 14971 (FMEA, hazard analysis, risk controls)
  • Ensure design solutions effectively mitigate patient and user risks
  • Support regulatory submissions (510(k), MDR, etc.) by providing design documentation
  • Participate in internal/external audits (FDA, notified bodies) and ensure audit readiness
• Cost Optimization & VAVE
  • Drive Value Engineering / Cost Optimization initiatives while maintaining compliance and product performance
  • Evaluate alternate materials, components, and manufacturing processes with full regulatory impact assessment
  • Partner with sourcing and suppliers to implement cost reduction strategies
• Supplier & Manufacturing Collaboration
  • Collaborate with global suppliers to ensure component quality and compliance
  • Support supplier qualification and design transfer activities
  • Partner with manufacturing sites to address design-related yield, reliability, and quality issues

• Researches, plans, designs, verifies, validates and develops mechanical and/or electromechanical products and systems, such as metals, instruments, controls, plastics, robots, engines, machines and mechanical, resonance, hydraulic or heat transfer systems for production, transmission, measurement, and use of energy.
• Recommends various technology options or approaches for system, processes, facility or program improvements in terms of safety, performance, efficiency or costs.
• May be responsible for the transfer from R&D to manufacturing.

An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.

Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.

May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in…