Provide process engineering support for sustainment and improvement of surgical instruments
Serve as the voice of operations in the development process
Work on design for manufacturability and assembly
Responsible for process design, development, and validation in new product development
Develop processes for electro-mechanical assembly including PCBA manufacturing, potting, soldering, pressing, plastic injection molding, torquing and manual assembly
Generate detailed electrical and electronic solutions and release applicable documentation
Work closely with manufacturing, quality assurance, other engineering teams, and program management to deliver products
Execute project plans
Review peer designed drawings
Contribute to the building and testing of electrical prototypes
Practice advanced understanding of manufacturing principles and quality assurance documentation in the medical industry
Lead or support capital acquisition activity from specifying equipment, contract negotiation, installation, and validation
Ensure quality of process and product as defined in the appropriate operation and material specifications
Select components and equipment based on analysis of specifications, reliability, and regulatory requirements
Work with quality engineers to develop component specific testing and inspection protocols
Analyze equipment to establish operating data, conduct experimental test and result analysis
Lead and/or participate in process review meetings
Participate in Process Failure Mode and Effect Analysis (PFMEA), Control Plan, SOP and Production Part Approval Process (PPAP) generation associated with product transfers and launches
Complete capability studies for in process inspection and generate subsequent Inspection documentation
Review and approval of validation documentation
Requirements
Bachelor’s degree (B.S.) in Engineering (Electrical, Mechatronics, Mechanical, Chemical preferred)
5+ years of experience in a manufacturing or R&D environment
Basic knowledge of electrical engineering principles
Experience working with the design of electronics (printed circuit boards, cables) with emphasis on manufacturability
Experience reading electrical schematics, CAD drawings and product architecture drawings
Experience with ICT, FCT, safety and functional testing
Experience with complex PCBA DFM & manufacturing
Experience with electromechanical assembly
Knowledge of analytical tools and statistical methods
Experience working in a highly regulated industry
Experience managing/working with a 3rd party equipment suppliers