Senior Manufacturing Engineer

4 weeks ago

Andover, Massachusetts, United States TransMedics Full time
Job Description:

TransMedics is seeking a highly skilled Senior Manufacturing Engineer to join our team in Andover, Massachusetts. As a key member of our Manufacturing Engineering department, you will be responsible for developing, maintaining, and improving manufacturing processes to support the production of our Organ Care System.

Key Responsibilities:
  • Develop and implement manufacturing processes and procedures to ensure high-quality products.
  • Collaborate with production staff to improve manufacturing processes and resolve technical issues.
  • Lead cross-functional teams to identify and implement process improvements and cost reductions.
  • Develop and maintain documentation, including manufacturing instructions, inspection procedures, and test protocols.
  • Participate in validation activities, analysis of production processes, and continuous improvement projects.
  • Mentor and train junior engineers and interns.
  • Lead activities with the Engineering and Operations teams to identify opportunities for process improvements and product design changes.
  • Work with cross-functional teams to resolve technical and quality-related issues.
Requirements:
  • 8+ years of experience in an FDA/ISO regulated Medical Device/Medical Equipment industry.
  • Prior experience in process development and manufacturing engineering, including process validations.
  • Experience leading the design, development, and validation of production fixtures and tooling.
  • Prior work experience leading the development of plastic assembly, hardware assembly, electromechanical assembly, and test processes.
  • Ability to work with Solidworks and/or Pro Engineer to create 3D models and drawings.
  • Experience using Minitab or similar statistical evaluation software/tools, Lean Six Sigma experience, and knowledge of statistical data analysis techniques.
  • Experience leading root cause investigations and CAPAs.
  • Proven track record of working in a fast-paced environment with demonstrated ability to adjust to changing priorities.
  • Ability to identify, prioritize, and resolve issues with minimal supervision.
  • Strong work ethic, effective oral and written communication skills, and excellent interpersonal skills.
Education:
  • BS in Engineering plus 8+ years of experience in an FDA/ISO regulated Medical Device/Medical Equipment industry, or equivalent education and years of experience.

TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability, or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.

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