Lead NPI Manufacturing Engineer

2 weeks ago


Andover, Massachusetts, United States TransMedics, Inc. Full time

The NPI Manufacturing team at TransMedics is actively seeking skilled professionals who are passionate about launching innovative products that can transform lives. Reporting to the NPI Manufacturing Manager within the Advanced Operations division, the Senior Manufacturing Engineer will play a pivotal role in advancing manufacturing excellence in a dynamic and rapidly expanding organization focused on revolutionizing Organ Transplantation.

KEY RESPONSIBILITIES:

  • Engage in NPI manufacturing initiatives related to the development of TransMedics perfusion set products and OCS offerings.
  • Utilize extensive expertise as a technical contributor for NPI Manufacturing efforts in new product development projects.
  • Coordinate and implement effective manufacturing processes to meet production capacity, efficiency, and quality benchmarks.
  • Create detailed manufacturing instructions and routers that provide clarity and precision.
  • Identify, specify, procure, and install necessary capital equipment, tooling, and fixtures for production use.
  • Lead PFMEA initiatives in collaboration with product development, quality assurance, and manufacturing engineering teams.
  • Direct DFM and DFA processes to establish manufacturing protocols for new product and enhancement initiatives.
  • Develop assembly and testing methodologies to ensure Critical to Quality (CTQ) standards are achieved.
  • Identify KPIV and KPOV metrics for process enhancement to ensure robust manufacturing operations.
  • Contribute to Process Validations (IQ, OQ, PQ) to facilitate smooth transitions to production.
  • Represent TransMedics in collaboration with both internal and external NPI design teams to ensure new processes are effectively transferred to manufacturing.
  • Collaborate and communicate effectively with cross-functional teams and leadership.
  • Perform additional tasks and responsibilities as required by TransMedics.

REQUIREMENTS:

  • 8+ years of experience in an FDA/ISO regulated medical device or equipment manufacturing environment.
  • Prior experience in NPI Manufacturing and/or Process Development, particularly with disposables and capital equipment.
  • Demonstrated experience in selecting and qualifying assembly equipment and automation technologies.
  • Proven expertise in various manufacturing and assembly technologies, with a focus on quality and cost efficiency.
  • Knowledge of injection molding and plastic joining techniques, including ultrasonic, RF, laser welding, and adhesive/solvent bonding.
  • Proficient in Solidworks for creating 3D models and drawings to support manufacturing assembly, fixtures, and tooling.
  • Experience with Lean Six Sigma methodologies and statistical data analysis techniques is advantageous; familiarity with Minitab or similar tools is preferred.
  • Strong analytical and decision-making capabilities.
  • Detail-oriented with exceptional organizational skills.
  • Able to work effectively in a collaborative, cross-functional team environment.
  • Excellent verbal and written communication skills.

EDUCATIONAL BACKGROUND:

  • Bachelor's degree in Mechanical Engineering or a related engineering discipline is required.


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