Key skills
AssemblyRNegotiation
About this role
Role Overview
- 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
Tech Stack
- Assembly
Benefits
- Health insurance
- 401(k)
- PTO (Paid Time Off)
- Professional development opportunities