Senior Mechanical Engineer – Product Development

TransMedics, Inc.•Andover, MA

3d•$149,350 - $164,850

About The Position

TransMedics in Andover, MA is seeking multiple Senior Mechanical Engineers – Product Development to lead the advancement of technology and products related to organ care systems (OCS), developing Class II and III disposables, durables, and accessories. Responsible for modeling, building, and testing new concepts, and iterating through the design process with 3D engineering software. Up to 5% domestic or international travel may be required. Position requires Bachelor’s Degree in Mechanical Engineering, Industrial Engineering, Plastics Engineering, Biomedical Engineering, or related field or foreign equivalent as determined by a credentials evaluation and five (5) years of progressively responsible medical device product development experience following FDA CFR 820, ISO 13485, and IEC 60601-1 regulations and standards, and designing complex parts and assemblies with 3D engineering software. Experience to include three (3) years leading the development of complex Class II or III disposables; designing injection molded disposables using plastic joining methods (ultrasonic/RF/laser welding and adhesive/solvent bonding); performing engineering analysis including tolerance analysis utilizing GD&T, FEA, and Engineering 1st principles; and prototype manufacturing, assembly, and engineering testing. Pre-employment screening required. Wage range $149,350.00 to $164,850.00 (commensurate with qualifications and experience). Resumes to Daneal Espada-Johnson, [email protected]. Employee Benefit: Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA Dental Vision Healthcare Flexible Spending Account Dependent Care Flexible Spending Account Short Term Disability Long Term Disability 401K Plan Pet insurance Employee Stock Purchase Plan 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.

Requirements

Bachelor’s Degree in Mechanical Engineering, Industrial Engineering, Plastics Engineering, Biomedical Engineering, or related field or foreign equivalent as determined by a credentials evaluation
five (5) years of progressively responsible medical device product development experience following FDA CFR 820, ISO 13485, and IEC 60601-1 regulations and standards, and designing complex parts and assemblies with 3D engineering software
three (3) years leading the development of complex Class II or III disposables
designing injection molded disposables using plastic joining methods (ultrasonic/RF/laser welding and adhesive/solvent bonding)
performing engineering analysis including tolerance analysis utilizing GD&T, FEA, and Engineering 1st principles
prototype manufacturing, assembly, and engineering testing

Responsibilities

lead the advancement of technology and products related to organ care systems (OCS)
developing Class II and III disposables, durables, and accessories
modeling, building, and testing new concepts
iterating through the design process with 3D engineering software