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, 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