TransMedics, Inc. · 19 hours ago
Principal Manufacturing Engineer-NPI
Andover, MA
Full-time
Onsite
Lead/Staff
$147K/yr - $184K/yr
10+ years expTransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. The Principal Manufacturing Engineer-NPI will lead the technical project for new product introduction manufacturing activities, ensuring efficient and compliant processes while collaborating with cross-functional teams.
Health CareMedicalMedical DeviceService IndustryWellness
Responsibilities
Serve as the technical project leader for NPI manufacturing activities, driving the development and commercialization of TransMedics perfusion set and OCS products
Provide strategic oversight of manufacturing readiness for new product introductions, ensuring alignment of engineering resources, project schedules, and cross-functional deliverables
Lead cross-functional collaboration with Product Development, Quality, Regulatory, Supply Chain, and Manufacturing Operations to ensure robust, scalable, and compliant processes
Coordinate, identify, and implement advanced manufacturing processes to ensure production capacity, efficiency, cost-effectiveness, and adherence to quality standards
Define project plans, timelines, and resources needed to support NPI manufacturing programs, ensuring accountability for milestones and deliverables
Apply in-depth technical expertise to specify, design, and validate equipment, tooling, fixtures, and automation used in production
Drive PFMEA, DFM/DFA, and design transfer activities to establish capable, efficient, and risk-mitigated manufacturing processes
Develop manufacturing assembly and test methods that ensure Critical to Quality (CTQ) and Critical to Assembly (CTA) requirements are met
Establish and track Key Performance Indicators (KPIs) and process capability metrics using statistical tools such as MSA, GR&R, and SPC
Represent TransMedics externally and internally as a manufacturing subject matter expert (SME), ensuring effective knowledge transfer to production and suppliers
Mentor and guide junior engineers and technical staff, fostering a culture of engineering rigor, accountability, and innovation
Perform other TransMedics tasks and duties as assigned/required
Qualification
Required
BS in Mechanical Engineering or related engineering discipline required
10+ years of experience in an FDA/ISO-regulated medical device or medical equipment manufacturing environment
Extensive experience in NPI Manufacturing, Process Development, and Design Transfer, including both disposables and capital equipment
Proven leadership in the selection, qualification, and scale-up of capital assembly equipment and automation
Preferred
Advanced degree preferred
Demonstrated expertise in automated assembly methods, robotics, automated inspection, and fixture/tooling design
Strong knowledge of injection molding and plastic joining techniques (ultrasonic/RF/laser welding, adhesive/solvent bonding)
Proficiency in SolidWorks for 3D modeling and design of assembly models, fixtures, and tooling
Lean Six Sigma experience and proficiency in statistical data analysis tools (Minitab or equivalent) strongly preferred
Strong project management skills, with demonstrated accountability for planning, execution, and delivery of NPI milestones
Exceptional leadership and interpersonal skills, with ability to influence and align cross-functional teams
Excellent verbal and written communication skills, with the ability to present technical and project information to leadership and stakeholders
Proven ability to thrive in a fast-paced, dynamic environment, with adaptability to shifting priorities
Ability to work independently with high competency, while also driving and coordinating team-based execution
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