Overview In this role you drive the design, development, and validation of components and processes used to generate, manipulate, transmit, and store electricity within medical devices. You collaborate with R&D and Manufacturing teams to translate design into cost-effective production, improve processes, and ensure quality and reliability. You will analyze data, conduct experiments, and implement process improvements that impact manufacturing performance and product quality. You work within a regulated environment to support rapid scale-up and maintain compliance with quality and standards, delivering tangible improvements. This position offers hands-on responsibility with cross-functional exposure,挑
Compensation / Benefits Responsibilities- Conduct complex experiments and coordinate with engineers/technicians
- Contribute design input to translate R&D into production processes
- Develop and document manufacturing procedures, tooling, and fixtures
- Initiate changes to design, tooling, and processes impacting manufacturing
- Create and revise SOPs and standards related to scheduling, cost control, and performance
- Develop, verify, and validate manufacturing processes
- Support preventive maintenance with Facilities and production equipment
- Identify and resolve manufacturing technical issues; partner with cross-functional teams
- Lead process analyses, defect reviews, and process improvement initiatives
- Manage multiple projects independently
Key requirements- Bachelor's degree in Engineering or related technical discipline (preferred)
- 5-8 years of relevant experience with non-technical degree; 2-5 years with Bachelor's; 1-3 years with Master's; 0-1 years with PhD
- Experience with schematic capture and PCB layout software
- Automation experience, including automated manufacturing cells or lines
- Experience in an FDA-regulated medical device environment (highly desirable)
- Experience supporting rapid scale-up of new products or manufacturing operations (beneficial)
- Strong communication skills; ability to read/interpret technical drawings
- Knowledge of Lean, Six Sigma, RCA/TQM methodologies; ability to lead corrective actions
- Understanding of electronic design, medical device design, analog/digital circuits, PCB, software systems, optics, human factors engineering
- IEC 60601-1 and IEC 60601-2 knowledge
- Leadership or people management experience is a plus
- Lean Six Sigma Green Belt certification preferred
- Strong written and verbal communication
- Good organizational and time management
- Collaborative team player
- Schematic capture and PCB layout
- Automation and manufacturing system design
- Lean, Six Sigma, RCA, TQM, SPC