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.