Senior Manufacturing Engineer

TransMedics, Inc.; Andover (MN); On-site; USD 95,000 - 130,000; Full time

Job summary

A leading medical technology company is seeking a Senior Manufacturing Engineer to enhance their Organ Care System production. This pivotal role involves driving process improvements, technical support for manufacturing, and mentoring junior engineers. The ideal candidate will have significant experience in the FDA/ISO regulated medical device industry, focusing on continuous improvement and team collaboration.

Qualifications

• 8+ years of experience in an FDA/ISO regulated Medical Device Industry.
• Experience in leading design and development of production fixtures.
• Ability to work with Solidworks to create models and drawings.

Responsibilities

• Drive process improvements and efficiency in manufacturing operations.
• Work hands on to develop and analyze existing production processes.
• Provide mentorship and training to junior engineers.

Skills

Manufacturing Engineering

Process Development

Continuous Improvement

Technical Expertise

Team Collaboration

Education

BS in Engineering

Tools

Solidworks

Minitab

Job description

Senior Manufacturing Engineer page is loaded

Senior Manufacturing Engineer

Apply locations Andover, MA time type Full time posted on Posted 30+ Days Ago job requisition id R-100443

Job Description:

TransMedics was founded to address the growing need for healthier organs for transplantation. We are focused on transforming the standard of care – increasing organ utilization, improving patient outcomes, and reducing transplant costs.

Location: Onsite Andover, MA

The Senior Manufacturing Engineer for OCS Systems plays a pivotal role in driving process improvements and efficiency in manufacturing operations. We are seeking an experienced and dynamic Senior Manufacturing Engineer to join our team.

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 analyze existing production processes.
• 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:

• 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.
• Must have manufacturing engineering experience 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, test processes and validations.
• Ability to work with Solidworks 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.
• Experience with additive manufacturing equipment and processes a plus.

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.

Welcome to TransMedics Careers!

Our Vision is to help save more patients' lives by becoming the trusted partner to transplant stakeholders worldwide and delivering the highest quality technology, service and clinical care.

TransMedics Group, Inc. (TMDX) is a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. We developed the Organ Care System, or the OCS, to replace a decades-old standard of care that we believe is significantly limiting access to life-saving transplant therapy for hundreds of thousands of patients worldwide. Our innovative OCS technology replicates many aspects of the organ’s natural living and functioning environment outside of the human body. As such, the OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment.

In concert with our OCS technology platform and OCS Connect app, which enables TransMedics and transplant clinicians to efficiently track, coordinate & communicate resource logistics for donor organs procured and maintained on OCS, TMDX launched its National OCS Program (NOP) in 2022: 16 regional hubs across the U.S. staffed by a dispersed workforce of experienced, on-staff OCS Perfusion Specialists & Cardiothoracic and Abdominal Donor Procurement Surgeons. These resources are mobilized on-demand via our own dedicated ground & aviation transportation logistics network, to retrieve and deliver allocated donor organs from anywhere in the U.S. – aiding U.S. Transplant Centers in bidding farewell to the time & distance limitations of cold storage & expand the pool of viable donor organs for their transplant recipients.