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Senior NPI Manufacturing Engineer

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TransMedics, Inc.

Sep 11

  • Job
    Full-time
    Senior Level
  • Andover
  • Quick Apply

AI generated summary

  • You need 8+ years in FDA/ISO medical device manufacturing, NPI experience, expertise in assembly tech, Solidworks proficiency, and strong analytical skills. BS in Mechanical Engineering required.
  • You will lead NPI manufacturing activities, develop processes, create instructions, manage equipment needs, conduct PFMEA, ensure quality standards, and collaborate with teams for efficient product transfer.

Requirements

  • QUALIFICATIONS:
  • 8+ 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 a variety of manufacturing and assembly technologies and able to effectively implement said technologies with quality and cost in mind.
  • 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.
  • Lean Six Sigma experience and knowledge of statistical data analysis techniques is a plus. Experience using Minitab or similar statistical evaluation software/tools preferred.
  • 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.

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 manufacturing instructions and routers with sufficient detail and clarity.
  • Identify, specify, acquire, and install capital equipment, tooling, and fixtures for use in production.
  • Lead PFMEA activities in coordination with product development, quality, and manufacturing engineering teams.
  • Lead 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.
  • Identify KPIV and KPOV metrics for process development, to ensure robust manufacturing processes.
  • Contribute to Process Validations (IQ, OQ, PQ) for efficient line transfer to production.
  • Represent TransMedics in collaboration with external and internal NPI 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.

FAQs

What is the main focus of the Senior NPI Manufacturing Engineer role?

The main focus of the Senior NPI Manufacturing Engineer role is to contribute to new product introduction (NPI) manufacturing activities for TransMedics' perfusion set products and OCS products, ensuring manufacturing excellence and process efficiency.

What qualifications are required for this position?

Candidates must have 8+ years of experience in an FDA/ISO regulated medical device manufacturing environment, prior NPI manufacturing and/or process development experience, proficiency in Solidworks, and a BS in Mechanical Engineering or related discipline.

Is prior experience in NPI and process development necessary?

Yes, prior NPI manufacturing and/or process development experience is a requirement for this position, particularly with disposables and capital equipment.

What type of manufacturing processes will I be responsible for developing?

You will be responsible for developing robust manufacturing processes, generating manufacturing instructions, identifying capital equipment, and ensuring production capacity, efficiency, and quality standards are met.

Are there opportunities for collaboration in this role?

Yes, the role involves collaborating and communicating with cross-functional teams and leadership, as well as representing TransMedics in collaboration with external and internal NPI design teams.

Does the position require knowledge of specific manufacturing technologies?

Yes, the position requires knowledge in a variety of manufacturing and assembly technologies, including injection molding and plastic joining techniques like ultrasonic/RF/laser welding and adhesive/solvent bonding.

Is Lean Six Sigma experience necessary for this role?

While Lean Six Sigma experience is a plus, it is not explicitly stated as a requirement. However, familiarity with statistical data analysis techniques is preferred.

What skills are emphasized for this position?

Effective analytical and decision-making skills, strong organizational abilities, attention to detail, and excellent verbal and written communication skills are emphasized for this position.

What is the team structure within the NPI Manufacturing group?

The Senior NPI Manufacturing Engineer will report to the NPI Manufacturing Manager and be part of the Advanced Operations group, working closely with various teams involved in product development and manufacturing engineering.

What type of educational background is necessary for this position?

A Bachelor’s degree in Mechanical Engineering or another engineering discipline is required for this position.

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TransMedics, Inc.

Redefining what's possible in organ transplantation

Science & Healthcare
Industry
501-1000
Employees
1998
Founded Year

Mission & Purpose

Every Organ Wasted is a Life Not Saved. TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, and clinical care. With more than 25 years of commitment to excellence and innovation, TransMedics is at the forefront of advancing the field of organ transplantation. Our innovative Organ Care System (OCS™) technology is the only FDA-approved technology for lung, heart and liver transplant indications in the U.S., enabling the optimization and assessment of donor organs outside the human body and replacing a decades-old outdated standard of care: static cold storage (ice). Combined with our National OCS Program (NOP), a nationwide team of clinical experts, 24/7 logistics support, and the first-of-its-kind dedicated air & ground transport logistics network, we are enabling transplant centers to expand their search criteria for viable organ donors and grow overall transplant volumes in the U.S.