Job Details
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