TransMedics, Inc. · 9 hours ago
Senior Manufacturing Quality Engineer
Andover, MA
Full-time
Onsite
Senior Level, Lead/Staff
$119K/yr - $148K/yr
8+ years expTransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. They are seeking a Senior Manufacturing Quality Engineer to develop, implement, and manage quality systems for manufacturing, focusing on process improvement, defect reduction, and compliance.
Health CareMedicalMedical DeviceService IndustryWellness
Responsibilities
Utilization of statistical data analysis for trending and investigation purposes
Ability to communicate ideas and information clearly, effectively, and concisely
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 improvements 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
Partner with manufacturing engineering to ensure necessary process controls and validations are in place and best practices are followed (GMP)
Partner with Manufacturing Engineering to implement and maintain electronic manufacturing and inspection work instructions within a Manufacturing Execution System (MES)
Oversee the inspection & testing of raw materials, components & finished products to ensure compliance with specifications & quality standards. Establish and maintain quality control procedures, including inspection methods and test protocols
Support internal and external auditing requirements in manufacturing to ensure compliance with quality system requirements
Support other Quality Engineering functions as required (supplier quality, service, design QA)
Perform other TransMedics task and duties as required
Qualification
Required
Bachelor's Degree in Mechanical, Electrical, or Biomedical Engineering or other scientific or related discipline
Minimum of 8 years' experience in a Manufacturing Quality and/or Manufacturing Engineering role
Experience with work instruction development and maintenance within an MES environment
Preferred
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 medical device products. 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
Experience with process validation
Experience with non-product software implementation and validation
Familiarity with Manufacturing Execution Systems (MES) software
Experience presenting data and information to management, including senior and/or executive management
Benefits
Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
Dental
Vision
Healthcare Flexible Spending Account
Dependent Care Flexible Spending Account
Short Term Disability
Long Term Disability
401K Plan
Pet insurance
Employee Stock Purchase Plan
Company
TransMedics, Inc.
Every Organ Wasted is a Life Not Saved. TransMedics, Inc.
Founded in 1998Andover, Massachusetts, USA
501-1000 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (4)
2023 (3)
2022 (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
President & CEO
Gerardo Hernandez
Chief Financial Officer
Recent News
thefly.com
2025-11-19
2025-11-01
2025-10-31
Company data provided by crunchbase