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, mainaining,
and improving manufacturing processes to support our initiavive 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.
- Work with production staff to develop manufacturing processes. Provide technical expertise
and support related to existing and new manufacturing processes and 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, data
collection 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 comply 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.
DocuSign Envelope ID: B313FCCE-7775-4BBE-960F-64C45B794A313
- Must have prior work experience leading the development of plastic assembly, hardware
assembly, electromechanical assembly, and test processes and validations.
- 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