New · posted Nov 15
TransMedics · Medical Devices
Senior Software Quality Engineer
- Andover, MA
- On-site
- Full-time
- Senior & Principal
The role
We are seeking a highly skilled and experienced Senior Software Quality Engineer to join our team. The ideal candidate will have a strong background in computer system validation, quality processes and IT, with a proven track record of successfully implementing software and IT systems. This role sits within Quality but works in close partnership with IT to implement and support systems that enable compliant, efficient, and scalable business processes.
The ideal candidate will bring a strong balance of technical aptitude and quality systems expertise, with the ability to independently execute system configurations, lead validation activities, and translate business needs into practical, compliant system solutions.
What you need
- 5+ years of experience implementing or supporting enterprise software systems (e.g. QMS, ERP, PLM, MES or similar platforms).
- Strong working knowledge of quality system processes (e.g., CAPA, complaints, audits, change control) in a regulated environment.
- Hands-on experience with system configuration, testing, validation, and troubleshooting.
- Experience with software validation principles (CSV/CSA) and data integrity requirements.
- Proven ability to work cross-functionally with both technical (IT) and non-technical stakeholders.
- Strong problem-solving skills with the ability to diagnose issues and independently drive resolution.
- Ability to manage multiple priorities and drive work forward in a fast-paced environment.
- Strong communication and collaboration skills.
Preferred Requirementsnice to have
- Experience in medical device, pharmaceutical, or other regulated industries.
- Experience supporting system integrations and working with APIs or data interfaces (high-level understanding).
- Experience with digital transformation initiatives and large-scale system implementations.
- Experience supporting global or multi-site system deployments.
- Ability to mentor others and provide technical guidance within the Quality
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, clinical care and outcomes.
Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health.
Maximize your potential at TransMedics, Inc.
TransMedics is committed to equitable and transparent compensation. The expected salary for this role is $95,000 - $110,000 which represents the company’s current good-faith estimate of compensation for this position. Actual hour rate will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. Hourly roles may also be eligible for overtime, shift differentials, incentive programs, and our comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history.
What you'll do
- Lead configuration, setup, and deployment of enterprise software systems supporting Quality and cross-functional processes.
- Perform independent review and approval of software validation documentation (e.g. plans, protocols, reports) as the Quality representative, ensuring compliance with regulatory and internal requirements.
- Partner closely with IT to support system integrations, data structures, access controls, and technical troubleshooting.
- Translate business and quality process requirements into system configurations, workflows, and scalable solutions.
- Lead and execute system validation activities (e.g., IQ/OQ/PQ, UAT), ensuring compliance with applicable regulatory requirements.
- Troubleshoot system issues, perform root cause analysis, and implement Support data migration, data integrity checks, and system updates/enhancements.
- Drive system testing efforts, including test strategy, defect tracking, and resolution
- Collaborate with cross-functional teams to manage dependencies and ensure seamless integration.
- Attend meetings, engage with consultants, and provide granular-level guidance
Pay
$95,000 – $110,000 a year
Employer providedMedical 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
Where you'll work
Andover, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Andover, MAEqual opportunity, accessibility and legal noticesTransMedics's statements, word for word
TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.
Job intelligence
The context around this role
Live data · November 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 22% below the US median for Software Quality & CSV roles at this level.
This roleEmployer provided
Senior & Principal roles in the US29 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $95,000 | — | $110,000 |
| All US (middle half) | $111,000 | $132,000 | $150,000 |
This role: TransMedics's own published range. Comparisons: the base pay employers published on open Software Quality & CSV roles at the same level on Regulatory Jobs, November 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Software Quality & CSV
The general path across 54 open Software Quality & CSV roles on Regulatory Jobs, with the titles they carry most. Not TransMedics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership10
- Data and digital systems8
- Validation and qualification6
- GMP and compliance3
- Quality systems and risk3
- Lab testing and methods2
- Documentation and SOPs2
- Investigations and CAPA2
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Software Quality & CSV work in medical devices, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system softwareNamed in the posting
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed in the posting
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device software
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- FDAFDA cybersecurity in medical devices(official source, opens in a new tab)Quality system considerations and premarket content for device cybersecurity
- IMDRFIMDRF(official source, opens in a new tab)International Medical Device Regulators Forum guidance, including software as a medical device
- IECIEC 62366-1(official source, opens in a new tab)Application of usability engineering to medical devices
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- IECIEC 60601-1(official source, opens in a new tab)Basic safety and essential performance of medical electrical equipment
Company hiring pulse
TransMedics on Regulatory Jobs
- 12
- Open roles
- 12
- Distinct roles
- 1
- Locations
By discipline
- Quality10 83%
- Regulatory1 8%
- Clinical1 8%
By level
- Senior & Principal5 42%
- Associate & Specialist5 42%
- Manager2 17%
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Senior Software Quality Engineer at TransMedics
Open until filled. $95K–$110K a year, employer provided.