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Medical Device Program Manager Jobs in Needham, MA

Senior Program Manager, SaMD

Boston, MA · On-site

$155K - $185K/yr

We are looking for a Senior Program Manager, SaMD to join our growing team and help scale the execution of our Software as a Medical Device programs. This role will partner closely with an existing ...

... Management Systems IEC 62366-1 - Usability Engineering IEC 62304 - Medical Device Software ... and regulated-device program timelines. Thrive under pressure and want to be continuously ...

Owning the sustainment program management for a portfolio of medical devices, including hardware, Software as a Medical Device (SaMD), and connected digital platforms. Ensuring products in the field ...

Process changes that affect medical device certifications (i.e., address, scope, employee count, and jurisdiction changes) * Work with program management, auditors, scheduling, sales, finance, and ...

Program Manager

Franklin, MA · On-site

$106K - $133K/yr

The Program Manager will also define the project's objectives. Role and Responsibilities · ... medical device-manufacturing environment is required. Must have experience with Class II & Class ...

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Showing results 1-20

Medical Device Program Manager information

See Needham, MA salary details

$41.9K

$117.1K

$171K

How much do medical device program manager jobs pay per year?

As of Jul 14, 2026, the average yearly pay for medical device program manager in Needham, MA is $117,064.00, according to ZipRecruiter salary data. Most workers in this role earn between $86,600.00 and $144,300.00 per year, depending on experience, location, and employer.

What is the difference between Medical Device Program Manager vs Medical Device Quality Engineer?

AspectMedical Device Program ManagerMedical Device Quality Engineer
CredentialsProject management certifications, engineering degreeQuality assurance certifications (e.g., CQE), engineering degree
Work EnvironmentCross-functional teams, project planning, product developmentQuality systems, compliance, testing, and validation
Employer & Industry UsageMedical device companies, manufacturing, R&DRegulatory agencies, manufacturing, quality departments
Search & Comparison IntentManaging projects, product launches, timelinesEnsuring quality, compliance, risk management

The Medical Device Program Manager focuses on overseeing product development projects, coordinating teams, and ensuring timely delivery. In contrast, the Medical Device Quality Engineer concentrates on maintaining quality standards, regulatory compliance, and testing processes. Both roles are essential in the medical device industry but serve different functions within the product lifecycle.

What are the key skills and qualifications needed to thrive as a Medical Device Program Manager, and why are they important?

To thrive as a Medical Device Program Manager, you need a strong background in project management, regulatory compliance, and biomedical engineering or a related field, often supported by a relevant degree and industry experience. Familiarity with project management tools (such as MS Project), quality management systems (QMS), and certifications like PMP or Six Sigma are highly valued. Exceptional leadership, cross-functional communication, and problem-solving skills help drive successful product development and team coordination. These competencies ensure programs meet regulatory standards, stay on schedule, and deliver safe, effective medical devices to market.

What is a Medical Device Program Manager?

A Medical Device Program Manager oversees the planning, development, and execution of projects related to medical devices within a company. They coordinate cross-functional teams, manage timelines, ensure regulatory compliance, and serve as the main point of contact for stakeholders. Their role is crucial in bringing safe and effective medical devices from concept to market, ensuring that all aspects of the program meet quality and regulatory standards. Medical Device Program Managers often work closely with engineering, quality assurance, regulatory affairs, and marketing teams.

How does a Medical Device Program Manager typically collaborate with cross-functional teams during product development?

A Medical Device Program Manager works closely with cross-functional teams including engineering, regulatory affairs, quality assurance, manufacturing, and marketing throughout the product development lifecycle. They coordinate timelines, facilitate communication, and resolve conflicts to ensure project milestones are met while maintaining compliance with regulatory standards. Regular meetings and progress updates are essential, as the Program Manager acts as a central point of contact to align various team goals and address issues proactively. This collaborative approach helps streamline development and supports successful product launches.
What job categories do people searching Medical Device Program Manager jobs in Needham, MA look for? The top searched job categories for Medical Device Program Manager jobs in Needham, MA are:
What cities near Needham, MA are hiring for Medical Device Program Manager jobs? Cities near Needham, MA with the most Medical Device Program Manager job openings:
Infographic showing various Medical Device Program Manager job openings in Needham, MA as of July 2026, with employment types broken down into 86% Full Time, 7% Contract, and 7% Nights. Highlights an 65% In-person, 14% Hybrid, and 21% Remote job distribution, with an average salary of $117,064 per year, or $56.3 per hour.
Senior Program Manager, SaMD

Senior Program Manager, SaMD

Whoop

Boston, MA • On-site

$155K - $185K/yr

Full-time

Re-posted 15 days ago


Job description

WHOOP is an advanced health and fitness wearable on a mission to unlock human performance. We empower our members to improve their health and perform at a higher level through a deeper understanding of their bodies and daily lives.
We are looking for a Senior Program Manager, SaMD to join our growing team and help scale the execution of our Software as a Medical Device programs. This role will partner closely with an existing Program Manager and cross-functional leaders to drive the successful delivery of regulated features.
This is an execution-focused role for someone who has experience working on end-to-end SaMD programs and can operate effectively within an established but evolving system.
RESPONSIBILITIES:
  • Drive execution of SaMD programs across the full product lifecycle, from development through regulatory submission and launch
  • Partner with Machine Learning, Product, Engineering, Clinical, Regulatory, and Quality to plan and deliver against program milestones
  • Work alongside an existing Program Manager to coordinate multiple SaMD initiatives, ensuring alignment across timelines and dependencies
  • Build and maintain detailed program plans, tracking progress against key deliverables and identifying risks early
  • Support development in compliance with design controls and regulatory requirements, ensuring documentation and processes are followed
  • Coordinate cross-functional activities including: Verification & validation, Clinical studies, Regulatory submission preparation, Design history file (DHF) documentation
  • Identify and proactively manage program risks and blockers, escalating as needed
  • Facilitate clear and consistent communication across stakeholders, including regular program updates
  • Help strengthen and scale program management processes as WHOOP expands its SaMD portfolio

QUALIFICATIONS:
  • 6 - 10+ years of program or project management experience
  • Hands-on experience working on at least one end-to-end SaMD program (from development through regulatory submission/clearance)
  • Familiarity with: FDA regulatory pathways (e.g., 510(k), De Novo), Design controls (21 CFR 820, ISO 13485) and SaMD development lifecycle
  • Experience working within or closely with Quality Management Systems (QMS)
  • Understanding of key standards such as: IEC 62304 & ISO 14971
  • Proven ability to coordinate across Product, Engineering, Clinical, and Regulatory teams
  • Strong organizational, communication, and stakeholder management skills
  • Experience in wearables, digital health, or consumer health products
  • Experience supporting clinical evidence generation or studies
  • Experience working across multiple concurrent programs
  • Background in a technical or scientific field

This role is based in the WHOOP office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office.
Interested in the role, but don't meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply.
WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility
The WHOOP compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values.
At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success.
The U.S. base salary range for this full-time position is $155,000 - $185,000. Salary ranges are determined by role, level, and location. Within each range, individual pay is based on factors such as job-related skills, experience, performance, and relevant education or training.
In addition to the base salary, the successful candidate will also receive benefits and a generous equity package.
These ranges may be modified in the future to reflect evolving market conditions and organizational needs. While most offers will typically fall toward the starting point of the range, total compensation will depend on the candidate's specific qualifications, expertise, and alignment with the role's requirements.

Whoop logo

About Whoop

Sourced by ZipRecruiter

At WHOOP, we're on a mission to unlock human performance. WHOOP empowers users (Olympians, Professional Athletes, Fitness Enthusiasts, etc) to perform at a higher level through a deeper understanding of their bodies and daily lives.

Industry

Fitness and sports centers

Company size

501 - 1,000 Employees

Headquarters location

Boston, MA, US

Year founded

2012