NPI Manufacturing Engineer
2 months ago
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Contribute to NPI manufacturing activities associated with the development of TransMedics perfusion set products and OCS products.
- Apply in-depth knowledge and experience as technical contributor for NPI Manufacturing activities for new product development initiatives.
- Coordinate, identify, and implement robust manufacturing processes to ensure production capacity, efficiency, and quality standards are being met.
- Generate and validate work instructions and test procedures.
- Specify, design, and install equipment, tooling and fixtures used in production.
- Lead PFMEA activities in coordination with product development, quality, and manufacturing engineering teams.
- Participate in DFM and DFA activities to define manufacturing processes for new product and product enhancement programs.
- Develop manufacturing assembly and test methods to ensure Critical to Quality (CTQ) requirements are met.
- Develop Critical to Assembly (CTA) requirements as required for manufacturing processes.
- Identify Key Performance Indicators and process capability metrics using Measurement System Analysis (MSA), Gage Repeatability and Reproducibility (GR&R), and Statistical Process Control (SPC) techniques.
- Represent TransMedics in collaboration with external and internal product development design teams to ensure new processes are capable and transferred effectively to manufacturing.
- Collaborate and communicate with cross-functional teams and leadership.
- Perform other TransMedics tasks and duties as required.
BACKGROUND AND QUALIFICATIONS:
- 5+ years of experience working in an FDA/ISO regulated medical device/medical equipment manufacturing environment.
- Must have prior NPI Manufacturing and/or Process Development experience, including disposables and capital equipment.
- Must have demonstrated experience in the selection and qualification of assembly equipment and automation.
- Demonstrated expertise in automated assembly methods, robotics, PLCs, automated inspection, and fixture design.
- Knowledgeable in injection molding and plastic joining techniques, including ultrasonic/RF/laser welding and adhesive/solvent bonding.
- Proficient with Solidworks to create 3D models and drawings to support manufacturing assembly models, fixtures, and tooling.
- Lean Six Sigma experience and knowledge of statistical data analysis techniques is a plus. Experience using Minitab or similar statistical evaluation software/tools preferred.
- Effective analytical and decision-making skills.
- Detail oriented with strong organizational skills.
- Able to work collaboratively in a cross-functional team environment.
- Excellent verbal and written communication skills.
EDUCATION:
- BS in Mechanical Engineering or other engineering discipline is required.
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