TransMedics
Principal Manufacturing Engineer-NPI
Andover, MA · Principal
Sponsorship not specified$147k-$184kDetected 30 days ago
Data AnalysisProject ManagementSupply ChainProcess ImprovementRecruitingSolidWorksRoboticsMechanical DesignPatient CareFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationAdaptabilityLean Manufacturing
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About the role
- The Principal Engineer - NPI Manufacturing serve as the technical project leader for NPI manufacturing activities, driving the development and commercialization of TransMedics perfusion set and OCS products.
Responsibilities
- 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.
Requirements
- BS in Mechanical Engineering or related engineering discipline required.
- Proven leadership in the selection, qualification, and scale-up of capital assembly equipment and automation.
- 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.
- Perform other TransMedics tasks and duties as required.
Nice to have
- 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.
- We believe this will be a place where we can continue to do things few thought possible in organ transplantation to help patients.
- Specific timing and role impact may vary.
Compensation
- TransMedics is committed to equitable and transparent compensation.
Company info
- As part of our long-term growth plans, TransMedics is excited to announce our plan to relocate our headquarters (HQ) to Somerville, MA by 2028.
- Our mission is to help save more patients' lives by increasing access to viable donor organs for those who are awaiting an organ transplant.
- Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do.
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This listing is sourced directly from TransMedics's careers page and normalized into a canonical job model.