TransMedics, Inc. · 2 weeks ago
Engineer III - NPI Manufacturing (Contract)
Andover, MA
Full-time, Contract
Onsite
Senior Level
5+ years expTransMedics, Inc. is a company focused on medical device manufacturing, and they are seeking an Engineer III for NPI Manufacturing. The role involves contributing to new product introduction activities, ensuring production processes meet quality standards, and collaborating with cross-functional teams.
Health CareMedicalMedical DeviceService IndustryWellness
Responsibilities
Contribute to NPI manufacturing activities associated with the development of TransMedics perfusion set products and OCS products
Apply in-depth knowledge and experience as technical contributor for NPI Manufacturing activities for new product development initiatives
Coordinate, identify, and implement robust manufacturing processes to ensure production capacity, efficiency, and quality standards are being met
Generate and validate work instructions and test procedures
Specify, design, and install equipment, tooling and fixtures used in production
Lead PFMEA activities in coordination with product development, quality, and manufacturing engineering teams
Participate in DFM and DFA activities to define manufacturing processes for new product and product enhancement programs
Develop manufacturing assembly and test methods to ensure Critical to Quality (CTQ) requirements are met
Develop Critical to Assembly (CTA) requirements as required for manufacturing processes
Identify Key Performance Indicators and process capability metrics using Measurement System Analysis (MSA), Gage Repeatability and Reproducibility (GR&R), and Statistical Process Control (SPC) techniques
Represent TransMedics in collaboration with external and internal product development design teams to ensure new processes are capable and transferred effectively to manufacturing
Collaborate and communicate with cross-functional teams and leadership
Perform other TransMedics tasks and duties as required
Qualification
Required
5+ years of experience working in an FDA/ISO regulated medical device/medical equipment manufacturing environment
Must have prior NPI Manufacturing and/or Process Development experience, including disposables and capital equipment
Must have demonstrated experience in the selection and qualification of assembly equipment and automation
Demonstrated expertise in automated assembly methods, robotics, PLCs, automated inspection, and fixture design
Knowledgeable in injection molding and plastic joining techniques, including ultrasonic/RF/laser welding and adhesive/solvent bonding
Proficient with Solidworks to create 3D models and drawings to support manufacturing assembly models, fixtures, and tooling
Effective analytical and decision-making skills
Detail oriented with strong organizational skills
Able to work collaboratively in a cross-functional team environment
Excellent verbal and written communication skills
EDUCATION: BS in Mechanical Engineering or other engineering discipline is required
Preferred
Lean Six Sigma experience and knowledge of statistical data analysis techniques is a plus
Experience using Minitab or similar statistical evaluation software/tools preferred
Benefits
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
Company
TransMedics, Inc.
Every Organ Wasted is a Life Not Saved. TransMedics, Inc.
Founded in 1998Andover, Massachusetts, USA
501-1000 employees
H1B Sponsorship
TransMedics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (4)
2023 (3)
2022 (1)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$721.33MKey Investors
CIBC Innovation BankingAbrams CapitalTudor Investments
2023-05-08Post Ipo Debt· $400M
2022-09-15Post Ipo Debt· $60M
2020-04-24Post Ipo Debt· $2.2M
Leadership Team
Waleed Hassanein
President & CEO
Gerardo Hernandez
Chief Financial Officer
Recent News
thefly.com
2025-11-19
2025-11-01
2025-10-31
Company data provided by crunchbase