As the Staff Electrical Engineer, you will provide process engineering support for sustainment and improvement of our surgical instruments, working with Marketing, R&D, Cost Accounting, Advanced Sourcing, and Advanced Quality. You will serve as the voice of operations in the development process and work on design for manufacturability and assembly. This position is responsible for process design, development, and validation in new product development.

• Work closely with internal and contract manufacturers to develop processes for electro-mechanical assembly including PCBA manufacturing, soldering, and manual assembly

• Design and develop requirements, prototypes, and electrical solutions for surgical applications

• Generate and release detailed electrical and electronic documentation

• Collaborate with manufacturing, quality assurance, engineering teams, and program management to deliver products

• Execute project plans

• Review peer-designed drawings

• Contribute to the building and testing of electrical prototypes

• Apply advanced understanding of manufacturing principles and quality system documentation within the medical device industry

• Lead or support capital acquisition activities including equipment specification, supplier engagement, installation, and validation

• Ensure process and product quality per applicable operational and material specifications

• Select components and equipment based on specifications, reliability, and regulatory requirements

• Partner with quality engineers to develop component-specific testing and inspection protocols

• Analyze equipment performance, conduct experimental testing, and evaluate results

• Lead and/or participate in process review meetings

• Participate in PFMEA, Control Plan, SOP, and PPAP activities associated with product transfers and launches

• Complete capability studies for in-process inspection and generate supporting inspection documentation

• Review and approve validation documentation

• Bachelor’s degree (B.S.) in Electrical Engineering

• 5+ years of experience in a manufacturing or R&D environment

• Basic knowledge of electrical engineering principles

• Experience designing electronics (printed circuit boards, cables) with emphasis on manufacturability

• Ability to read electrical schematics, CAD drawings, and product architecture drawings

• Experience with ICT, FCT, safety, and functional testing

• Experience with complex PCBA DFM and manufacturing

• Experience with electromechanical assembly

• Knowledge of analytical tools and statistical methods

• Experience working in a highly regulated industry

• Experience managing or working with third-party equipment suppliers