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$147k–$184k/yr
Full-time
bachelor degree, postgraduate degree
Medical Insurance, Health Reimbursement Account, Dental Insurance, Vision Insurance, Healthcare Flexible Spending Account, Dependent Care Flexible Spending Account
Posted 3d ago
~40 hrs/week
Responsibilities
Lead the end-to-end development and commercialization of complex medical device systems integrating hardware, disposables, and software. Manage comprehensive program plans, budgets, and cross-functional teams while ensuring strict adherence to regulatory standards and quality controls.
Requirements
Requires a Bachelor's degree in Engineering or Life Sciences and at least 8 years of program management experience in a regulated medical device or biotech industry. Preferred qualifications include an MBA, PMP certification, and experience with Class II or III medical devices.
Full job description
Job Description:
Please note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships
POSITION SUMMARY
We are seeking a highly motivated and experienced Program Manager to lead cross-functional teams in the development and commercialization of innovative medical device products, including capital equipment, disposable components, and software-enabled systems. This role requires strong leadership, technical acumen, and program management expertise to ensure that product development efforts align with company objectives, regulatory requirements, and market expectations.
RESPONSIBILITIES
This position is responsible for, but not limited to, the following:
Lead end-to-end program execution for complex medical device systems that integrate capital equipment, disposables, and embedded software components.
Develop and manage comprehensive program plans, including scope, schedules, budgets, and resource allocation, to deliver new product development projects on time and within budget.
Lead the creation and management of comprehensive program schedules, including detailed Gantt charts and Work Breakdown Structures (WBS); analyze critical paths, key workstreams, and interdependencies to proactively manage timeline risks.
Coordinate with cross-functional teams including R&D, Quality, Regulatory, Clinical, Operations, and Commercial to achieve program goals.
Manage dependencies and integration points between hardware, disposable, and software development streams, ensuring synchronized timelines and risk mitigation strategies.
Oversee design control activities for all device components, ensuring robust documentation, traceability, and regulatory readiness.
Manage vendor relationships for third-party components, including software platforms, contract manufacturers, and testing partners.
Serve as the primary point of contact for program communications, both internally and externally, including with senior leadership and strategic partners.
Coach and mentor team members on all aspects of project management, including planning, execution, risk mitigation, stakeholder communication, and delivery best practices to ensure consistent project success and team development
Ensure compliance with relevant regulatory standards (e.g., FDA 21 CFR 820, ISO 13485, EU MDR).
Facilitate phase gate reviews and ensure documentation meets quality and regulatory standards.
Track and report on key program metrics, escalate issues appropriately, and drive resolutions.
Identify and implement process improvements to enhance program delivery and team efficiency.
Lead continuous improvement initiatives to optimize program management processes.
All other duties as assigned
MINIMUM QUALIFICATIONS
Bachelor’s degree in Engineering, Life Sciences, or a related technical field;
8+ years of experience in program or project management within the medical device, biotech, or FDA/ISO regulated industry.
PREFERRED SKILLS
Master’s degree or MBA preferred.
Experience with Class II or Class III medical devices.
Demonstrated experience managing full product lifecycle projects, including design control and regulatory submission processes.
Proven track record leading cross-functional teams and delivering FDA-regulated products.
Strong knowledge of quality systems and regulatory requirements (FDA, ISO, etc.).
PMP or similar certification.
Excellent organizational, leadership, and communication skills.
Ability to manage multiple priorities and thrive in a fast-paced, dynamic environment.
Proficiency with project management tools (e.g., MS Project, Smartsheet, JIRA, etc.)..
Background in systems engineering or integration of hardware/software platforms.
Familiarity with clinical trial planning and execution.
Working knowledge of risk management (ISO 14971), usability engineering, and design verification/validation.
As part of our long-term growth plans, TransMedics is excited to announce our plan to relocate our headquarters (HQ) to Somerville, MA by 2028. We chose this location because we believe it is a place where innovation will thrive. Our new state-of-the-art headquarters is designed to support collaboration, creativity, and discovery. We believe this will be a place where we can continue to do things few thought possible in organ transplantation to help patients. Specific timing and role impact may vary.
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, 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.
TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $147,200.00 – $183,600.00, which represents the company’s current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a 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.
Employee Benefit:
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
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.
Related keywords
Medical DevicesCapital EquipmentEmbedded SoftwareFDAISO 13485EU MDRISO 14971Design VerificationDesign ValidationPMPMS ProjectSmartsheetJIRAClass II Medical DevicesClass III Medical DevicesPhase Gate Reviews
Redefining what's possible in organ transplantation
Industry
Medical Equipment Manufacturing
Company size
501-1,000 employees
Founded
1998
Headquarters
Andover, MA
LinkedIn followers
24,416
Total funding
$721M
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.
www.TransMedics.com
Offices: 200 Minuteman Road, Suite 302, Andover, MA 01810, US
Service IndustryHealth CareMedical DeviceWellnessMedical
How many Healthcare jobs are open in Andover, MA right now?
There are currently 96 open healthcare positions in Andover, MA listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Andover, MA?
Companies currently hiring include TransMedics, Inc., Straumann Group, CVS Health, Eurofins Viracor, Pfizer, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Andover, MA?
Yes — 9 of the 96 open healthcare positions offer remote or hybrid work (1 remote, 8 hybrid).
How do I apply for Healthcare jobs in Andover, MA?
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