DescriptionJob Title: Staff Manufacturing Engineer
Department: Manufacturing Engineering
Employment Type: Full-time
Position SummaryThe Staff Manufacturing Engineer will provide process engineering and controls support to develop, transfer, optimize, and sustain manufacturing processes for medical device manufacturing in an ISO 13485 compliant setting. Ensure projects meet all required quality, cost, capacity and regulatory requirements while adhering to company policy and best industry practices.
Key Accountabilities- Support Design Transfer from R&D to manufacturing: define processes, tooling, test methods, cell layout, and work instructions.
- Develop and improve manufacturing processes and Work Instructions using continuous improvement methodologies.
- Own NC/CAPA records related to production components/processes and drive corrective and preventative action plans to completion.
- Build business cases to implement new technologies and applications which streamline business processes, including Machine Learning, Artificial Intelligence tools, record digitization, automated test data collection, vision systems, ect.
- Establish working relationships with component manufacturers and provide technical feedback as required.
- Documentation & training: create process documentation, training materials, and guide technicians/operators through implementation.
- Design test methods to ensure process/product quality.
- Provide technical direction and leadership to project team members in investigation and experimentation efforts aimed at practical applications of scientific theories or principles
- Provide technical leadership to product development team
- Provide support as a Subject Matter Expert during internal/external audits for Quality and Regulatory Compliance.
- Provides complex design reviews and feedback for improvements in manufacturability.
Education, Experience & Skills- Bachelor's degree in Industrial, Mechanical, Electrical, Software Engineering, or a related field preferred; equivalent direct experience will also be considered.
- Typically 4-8 years' experience with mechanical/electrical manufacturing processes, including assembly and testing.
- Medical device manufacturing experience.
- Experience leading cross functional project teams or supervising staff is desirable.
- DFMEA (design failure mode effect analysis) principles, PFMEA (process failure mode effect analysis) principles, AFMEA ((application) failure mode effect analysis) principles.
- Working knowledge of mechanical testing of systems, sub-systems, and components.
- Knowledge of intellectual property fundamentals and legal processes for managing intellectual art.
Physical Requirements- Sit or stand for 8-10 hours per day.
- Lift up to 20 lbs.
LocationThis position will be based in Madison, WI with ~10-20% domestic and international travel.
