37 applicants
TransMedics, Inc. · 1 week ago
Quality Engineer
Andover, MA
Full-time
Onsite
Mid, Senior Level
5+ years exp
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Hiring Manager
Jeff Delle Chiaie
Insider Connection @TransMedics, Inc.
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.
Qualification
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Required
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
Preferred
Experience with medical capital equipment and electromechanical devices
Company
TransMedics, Inc.
TransMedics Inc. is the world’s leader in portable ex-vivo perfusion and assessment of donor organs for transplantation.
Founded in 1998Andover, Massachusetts, USA
501-1,000 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
Trends of Total Sponsorships
2023 (1)
2022 (1)
2021 (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
Founder, President and CEO
Anil Ranganath
Senior Vice President, General Counsel, and Corporate Secretary
Recent News
2024-06-05
Seeking Alpha
2024-06-05
Company data provided by crunchbase
