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Medical Device Program Manager Jobs in Silver Spring, MD

This position reports to the Regional Sales Manager and is part of the Blood Gas Sales Team and ... in a medical device industry preferred * 1+ years capital equipment sales experience preferred ...

JOB TITLE: Program Manager POSITION SUMMARY : The Program Manager role within the Project ... Preferred experience in the pharmaceutical, medical device, biotech or healthcare hub services ...

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Medical Device Program Manager information

See Silver Spring, MD salary details

$39.8K

$111.1K

$162.3K

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

As of Sep 14, 2026, the average yearly pay for medical device program manager in Silver Spring, MD is $111,090.00, according to ZipRecruiter salary data. Most workers in this role earn between $82,200.00 and $137,000.00 per year, depending on experience, location, and employer.

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 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 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 popular job titles related to Medical Device Program Manager jobs in Silver Spring, MD?

For Medical Device Program Manager jobs in Silver Spring, MD, the most frequently searched job titles are:

What job categories do people searching Medical Device Program Manager jobs in Silver Spring, MD look for?

The top searched job categories for Medical Device Program Manager jobs in Silver Spring, MD are:

What cities near Silver Spring, MD are hiring for Medical Device Program Manager jobs?

Cities near Silver Spring, MD with the most Medical Device Program Manager job openings:

Infographic showing various Medical Device Program Manager job openings in Silver Spring, MD as of September 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $111,090 per year, or $53.4 per hour.

Combination Product (Medical Device) Reviewer

Bethesda, MD • On-site, Remote

Full-time

Posted 12 days ago


Key responsibilities

  • Review pre-market submissions such as INDs, NDAs, BLAs, PMAs, and 510(k)s to assess interactions between drug/biologic and device components.

  • Consult with cross-center experts and the Office of Combination Products to ensure aligned regulatory feedback.

  • Assess design controls, human factors, and drug delivery outputs for complex combination therapies.


Job description

Combination Product (Medical Device) Reviewer 

The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.

The Office of Clinical Evidence and Analysis within CDRH's Office of Product Evaluation and Quality (OPEQ) provides policy and program support regarding clinical trials, biostatistics, real-world evidence, epidemiological analysis and outreach and collaboration with hospitals and other external stakeholders.

Tunnell Government Services, Inc. is providing professional and scientific services to CDRH with expert consultants with scientific expertise in the regulation and approval and of medical devices. In general, these consultants provide consultation related to supporting medical device reviews (EUA, 510(k), PME and De Novo marketing applications, Pre-submissions); participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders; develop written reviews and correspondence; write detailed documents and reports; and execute other administrative tasks related to CDRH's projects.

Tunnell is seeking a candidate to provide expert consulting services to assist the CDRH with their regulatory responsibilities, specific to the evaluation of pre-market submissions and lifecycle applications for medical products that combine medical devices with drugs and/or devices (e.g., drug-eluting stents, pre-filled syringes, inhalers).

This candidate should possess specific expertise and applicable training in regulatory scientific review, as relevant to:

  • Evaluating medical device investigations and clinical data to support regulatory decisions.
  • Ensuring clinical trial designs, biostatistics, and real-world evidence (RWE) comply with human subject protection standards and safety regulations before devices reach the market.

Key Duties and Responsibilities

  • Submission Evaluation: Review INDs, NDAs, BLAs, PMAs, and 510(k)s to assess how drug/biologic and device components interact.
  • Interdisciplinary Collaboration: Consult with cross-center experts (CDER, CDRH, CBER) and the Office of Combination Products to ensure aligned, consolidated regulatory feedback.
  • Design & Performance Review: Assess design controls, human factors (usability), and essential drug delivery outputs for complex combination therapies.
  • Guidance & Policy: Under direction of federal personnel, advise sponsors in pre-submission meetings and help develop or implement agency guidance documents.
  • Deficiency Identification: Draft formal deficiency letters for manufacturers if additional non-clinical, clinical, or manufacturing data is required.

Qualifications

  • The candidate must possess a bachelor's degree (BS) in a relevant field
  • An advanced degree (MD, MS, PhD) in a related/applicable field is strongly preferred.
  • 5-7 years of applicable experience is required, however advanced degrees can substitute for professional work experience
  • Candidates must demonstrate advanced professional experience in scientific, regulatory, or clinical research environments. Key background experiences include:
    • Trial Evaluation: Background evaluating clinical trial designs, bioequivalence data, and statistical protocols.
    • Regulatory Knowledge: Familiarity with the Federal Food, Drug, and Cosmetic (FD&C) Act, FDA guidance documents, and Good Clinical Practice (GCP) standards.
    • Industry Experience: Prior experience inside the medical device or pharmaceutical industry managing product lifecycles, clinical outcomes, or postmarket safety data.
  • Ability to communicate well with others using excellent written and verbal communication skills.
  • Excellent interpersonal skills, with the ability to effectively work both independently and within a team of technical personnel.
  • Proficiency with Microsoft Office Suite (Outlook, Word, Excel, etc.)

Job Type:  Full Time

Schedule:  Monday through Friday (No Holidays)

Location:  This position is 100% telework. 

Must be a US Citizen or Full Green Card holder.