Senior Electrical Engineer, Advanced Operations

StrykerPortage, MI
12dHybrid

About The Position

As the Senior Electrical Engineer, you will support the sustainment and improvement of surgical instruments through process engineering, cross‑functional collaboration, and design-for-manufacturability. You will represent Operations in product development and lead process design, development, and validation activities. Work with internal teams and contract manufacturers to develop and refine electro‑mechanical and PCBA assembly processes Design and develop electrical requirements, prototypes, and solutions for surgical applications Generate, review, and release detailed electrical and electronic documentation Collaborate with Manufacturing, Quality, Engineering, Sourcing, and Program Management to deliver high‑quality products Execute project plans and support development timelines Review peer design drawings and contribute to prototype builds and testing Apply advanced manufacturing and quality system principles within a regulated medical device environment Lead or support capital equipment activities including specification, supplier engagement, installation, and validation Ensure process and product quality meet operational and material standards Select components and equipment based on performance, reliability, and regulatory requirements Partner with Quality Engineering on testing and inspection protocols Analyze equipment performance, conduct testing, and evaluate results to drive improvements Participate in process reviews and continuous improvement activities Support PFMEA, Control Plan, SOP, and PPAP work for product transfers and launches Conduct capability studies and produce supporting inspection documentation Review and approve validation documentation

Requirements

  • Bachelor’s degree in Electrical Engineering
  • 2+ years of experience in a manufacturing or R&D environment

Nice To Haves

  • Experience designing electronics (PCBs, cables) with a focus on manufacturability
  • Ability to read electrical schematics, CAD drawings, and architecture documents
  • Experience with ICT, FCT, safety, and functional testing
  • Experience with complex PCBA DFM and electromechanical assembly
  • Knowledge of analytical tools and statistical methods
  • Experience in highly regulated industries
  • Experience working with third‑party equipment suppliers

Responsibilities

  • Support the sustainment and improvement of surgical instruments through process engineering, cross‑functional collaboration, and design-for-manufacturability
  • Represent Operations in product development and lead process design, development, and validation activities
  • Work with internal teams and contract manufacturers to develop and refine electro‑mechanical and PCBA assembly processes
  • Design and develop electrical requirements, prototypes, and solutions for surgical applications
  • Generate, review, and release detailed electrical and electronic documentation
  • Collaborate with Manufacturing, Quality, Engineering, Sourcing, and Program Management to deliver high‑quality products
  • Execute project plans and support development timelines
  • Review peer design drawings and contribute to prototype builds and testing
  • Apply advanced manufacturing and quality system principles within a regulated medical device environment
  • Lead or support capital equipment activities including specification, supplier engagement, installation, and validation
  • Ensure process and product quality meet operational and material standards
  • Select components and equipment based on performance, reliability, and regulatory requirements
  • Partner with Quality Engineering on testing and inspection protocols
  • Analyze equipment performance, conduct testing, and evaluate results to drive improvements
  • Participate in process reviews and continuous improvement activities
  • Support PFMEA, Control Plan, SOP, and PPAP work for product transfers and launches
  • Conduct capability studies and produce supporting inspection documentation
  • Review and approve validation documentation
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