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Engineer III - NPI Manufacturing

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TransMedics, Inc.

Sep 11

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

AI generated summary

  • You need 5+ years in FDA/ISO medical device manufacturing, NPI experience, automation skills, Solidworks proficiency, lean Six Sigma knowledge, and a BS in Mechanical Engineering.
  • You will contribute to NPI manufacturing, develop robust processes, generate work instructions, lead PFMEA, collaborate with teams, and ensure quality and efficiency in production activities.

Requirements

  • - 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.
  • - 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.
  • - 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 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.

FAQs

What is the primary focus of the Engineer III - NPI Manufacturing position?

The primary focus is to contribute to NPI manufacturing activities associated with the development of TransMedics perfusion set products and OCS products.

What qualifications are required for this position?

A BS in Mechanical Engineering or another engineering discipline is required, along with 5+ years of experience in an FDA/ISO regulated medical device manufacturing environment.

Is prior NPI manufacturing experience necessary?

Yes, prior NPI Manufacturing and/or Process Development experience, including disposables and capital equipment, is required.

What tools or software proficiency is expected for this role?

Proficiency with Solidworks to create 3D models and drawings is required, and experience with Minitab or similar statistical evaluation software/tools is preferred.

What critical skills are emphasized for candidates applying for this position?

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

Will the Engineer III - NPI Manufacturing work independently or within a team?

The position requires collaboration and communication with cross-functional teams, indicating that working within a team environment is essential.

What type of manufacturing techniques should applicants be knowledgeable about?

Applicants should be knowledgeable in automated assembly methods, robotics, injection molding, and plastic joining techniques, including ultrasonic/RF/laser welding and adhesive bonding.

Is Lean Six Sigma experience considered advantageous for this position?

Yes, Lean Six Sigma experience and knowledge of statistical data analysis techniques are considered a plus for this role.

What are the essential duties related to manufacturing processes in this position?

Essential duties include coordinating and implementing robust manufacturing processes, generating and validating work instructions, leading PFMEA activities, and developing manufacturing assembly and test methods.

Does TransMedics promote diversity in the workplace?

Yes, TransMedics is an equal opportunity employer and is committed to creating an inclusive environment for all employees.

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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.