Senior NPI Manufacturing Engineer

NPI Manufacturing - Advanced Operations

Transmedics New Product Introduction (NPI) Manufacturing team is currently seeking talented candidates interested in bringing life changing new products to market. Reporting to the NPI Manufacturing Manager, within the Advanced Operations group, the Sr Manufacturing Engineer will have the opportunity to push the boundaries of manufacturing excellence for an exciting, fast-growing company that is transforming Organ Transplantation.

ESSENTIAL FUNCTIONS:

• 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 manufacturing instructions and routers with sufficent detail and clarity.

• Identify, specify, acquire, and install capital equipment, tooling, and fixtures for use in production.

• Lead PFMEA activities in coordination with product development, quality, and manufacturing engineering teams.

• Lead 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.

• Identify KPIV and KPOV metrics for process development, to ensure robust manufacturing processes.

• Contribute to Process Validations (IQ, OQ, PQ) for efficient line transfer to production.

• Represent TransMedics in collaboration with external and internal NPI 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.

QUALIFICATIONS:

• 8+ 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 a variety of manufacturing and assembly technologies and able to effectively implement said technologies with quality and cost in mind.

• 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.