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Manufacturing Quality Engineer

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TransMedics, Inc.

Sep 11

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

AI generated summary

  • You must have 5+ years in Manufacturing Quality/Engineering, FDA/ISO knowledge, experience with complex medical devices, problem-solving skills, and proficiency in statistical tools. BS in relevant field required.
  • You will ensure compliance in manufacturing, drive nonconformance processes, analyze production data, support inspections, resolve yield issues, and assist in internal audits.

Requirements

  • Minimum of 5 years’ experience in a Manufacturing Quality and/or Manufacturing Engineering role
  • Working knowledge of Medical Device Regulations: FDA 21 CFR 820, ISO 14971 & 13485 as well other applicable regulations and industry standards pertaining to Medical Devices.
  • Experience with manufacturing of complex products in an Environmentally controlled area. Experience with medical capital equipment and electromechanical devices preferred.
  • Experience with formal problem-solving methodologies and deductive skills, root cause analysis & CAPA.
  • Experience with handling non-conforming material and assemblies.
  • Practical knowledge and experience using Minitab or other statistical analysis tools. Understanding & application of Gage R&R and Measurement system analysis desired.
  • Utilization of statistical data analysis for trending purposes; ideally Six Sigma methods and tools
  • Ability to communicate ideas and information clearly, effectively, and concisely.
  • BS in Mechanical, Electrical, or Biomedical Engineering or other scientific or related discipline.

Responsibilities

  • - Provide quality engineering support in the manufacturing of medical devices & hardware.
  • - Ensure compliance of manufacturing processes and areas to all applicable quality system regulations.
  • - Lead Nonconformance (NCMR) process such as inspection methods, containment, correction, closure and CAPAs, and drive continuous improvement through analysis of trend data.
  • - Monitor and analyze production information to support risk management and to provide direction for corrective and preventive actions and/or process improvement activities.
  • - Work with manufacturing engineering to ensure necessary process controls and validations are in place and best practices are followed (GMP).
  • - Support the inspection & testing of raw materials, components & finished products to ensure compliance with specifications & quality standards.
  • - Resolve incoming inspection yield issues by driving tighter vendor process capabilities, ensuring appropriate internal drawing specifications, and validation of inspection methods.
  • - Lead analysis of defective components found in Incoming Inspection and work with suppliers to resolve (SCARs).
  • - Support internal auditing requirements in manufacturing to ensure compliance with quality system requirements.

FAQs

What is the primary responsibility of the Manufacturing Quality Engineer at TransMedics?

The primary responsibility is to provide quality engineering support in the manufacturing of medical devices and hardware, ensuring compliance with applicable quality system regulations.

What qualifications are required for this position?

A minimum of 5 years’ experience in a Manufacturing Quality and/or Manufacturing Engineering role, along with a BS in Mechanical, Electrical, or Biomedical Engineering or a related discipline.

Which regulatory standards should applicants be familiar with?

Applicants should have a working knowledge of Medical Device Regulations including FDA 21 CFR 820, ISO 14971 & 13485, and other applicable regulations and industry standards pertaining to Medical Devices.

What type of experience is preferred for this role?

Experience with manufacturing complex products in an environmentally controlled area, medical capital equipment, and electromechanical devices is preferred.

What tools or methodologies should candidates be experienced with?

Candidates should have experience with formal problem-solving methodologies, root cause analysis, CAPA, and practical knowledge of statistical analysis tools like Minitab, including Gage R&R and Measurement System Analysis.

Is prior experience with non-conforming materials necessary?

Yes, experience with handling non-conforming material and assemblies is an important qualification for this role.

Does TransMedics offer training and development opportunities?

Yes, TransMedics is dedicated to attracting and hiring top talent, which indicates a commitment to employee development and training.

What is the company's stance on equal employment opportunities?

TransMedics is an equal opportunity employer and does not discriminate based on race, color, religion, sex, national origin, marital status, age, disability, protected veteran status, or any other characteristic protected by law.

Is relocation assistance offered for this role?

The job posting does not specify relocation assistance, so candidates are encouraged to inquire directly during the application process.

What should candidates be aware of regarding potential recruitment fraud?

Candidates should be cautious of individuals posing as representatives of TransMedics offering fake job opportunities. TransMedics does not ask for payment or financial information during the recruitment process.

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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.