Location: Cleveland, OH
Primary Responsibilities:
- Manufacturing Engineering
- Support cost improvements including performing detailed cost analysis and compliance impact.
- Support in the resolution of manufacturing issues (NCMR and CAPA support).
- Generate and maintain manufacturing specifications, production BOMs, drawings, inspection plans, labeling, and other product documents.
- Generate and maintain BOMs and routings in ERP system.
- Evaluate product flow and propose process improvements to maximize efficiencies in new and established manufacturing processes.
- Support the transfer of new products and product changes to production (pilot and full-scale).
- Process Development and Validation
- Support the design and development of manufacturing processes for new products, product changes and enhancements, and related tooling and fixtures.
- Review manufacturing process validation activities.
- New Product Development Support
- Partner with Product Development staff to ensure that products under development are designed for manufacture.
- Support Process Failure Modes and Effects Analyses (pFMEAs).
- Prepare estimates of time and cost for production qualification and production transfer projects.
- Generate manufacturing specifications, production BOMs, drawings, inspection plans, labeling and other product documents.
Job Requirements:
- Bachelor’s degree in Manufacturing Engineering or related field.
- Prefer 1-2 years of experience with FDA/GMP regulated medical device manufacturing.
- Will consider recent graduate with Manufacturing Engineering Co-op/Internship experience.
- Project management including planning, execution, and meeting time and budget constraints.
- Understanding of medical device DHF, DMR, and DHR files management and documentation requirements.
- Understanding of IQ, OQ and PQ product and process validation activities.
Why Join Our Team?
- Entrepreneurial work environment – A growth oriented and collaborative atmosphere in the medical device industry!
- Opportunity to work with game changing technology
- Competitive compensation and benefits
- Employee Wellness Program