Senior Manufacturing Engineer

Job Description:
Position: Senior Manufacturing Engineer
Reports to: Manufacturing Engineering Manager
DEPARTMENT OF MANUFACTURING ENGINEERING focuses on manufacturing of the Organ Care System at our headquarters in Andover, Massachusetts. The team works on developing, maintaining, and improving manufacturing processes to support our initiative to deliver the highest quality technology to save patients' lives.
ESSENTIAL TASKS AND DUTIES:

• Manufacturing Engineering activities associated with the production of TransMedics Organ Care System.
• Provide technical expertise and support related to existing and new manufacturing processes. Work directly with production staff to improve, maintain, and provide support to such processes.
• Work hands on to develop manufacturing processes, participate in validation activities, and analysis of production process.
• Complete continuous improvement project initiatives focused on improving product quality and reducing cost.
• Provide mentorship and training to Jr level engineers and interns.
• Creation of documentation including: manufacturing instructions, inspection procedures, test protocols, assembly drawings, equipment control documentation, and component drawings.
• Lead activities with the Engineering and Operations teams to identify opportunities to streamline production through process improvements, test improvements, and product design changes.
• Work with cross functional teams to identify and resolve technical and quality related issues including participation in MRB, customer complaint investigations, CAPA related activities, design activities, and regulatory submissions.
• Serve as strong team player, supporting and assisting supervisor and colleagues when necessary and complying with all work safety rules and regulations.
• Perform other TransMedics tasks and duties as required.

BACKGROUND AND QUALIFICATIONS:

• 8+ years of experience working in an FDA/ISO regulated Medical Device/ Medical Equipment Industry
• Must have prior Process Development and/or Manufacturing Engineering experience including the development and execution of Process Validations to support new and existing process and test equipment.
• Must have prior experience leading the design, development, and validation of production fixtures and tooling.
• Previous experience working directly with production staff to improve manufacturing processes.
• Must have 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 to support manufacturing assembly models, fixture design and development, and sustaining engineering activities.
• Experience using Minitab or similar statistical evaluation software/tools, Lean Six Sigma experience and knowledge of statistical data analysis techniques is a plus.
• 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.
• Must have ability to identify, prioritize, and resolve issues as they arise with minimal supervision.
• Must possess a strong work ethic, effective oral and written communication skills, and excellent interpersonal skills.

EDUCATION:

• BS in Engineering plus 8+ years of experience working 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.