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How much do medical device development jobs pay per year?

As of Jun 5, 2026, the average yearly pay for medical device development in the United States is $53,418.00, according to ZipRecruiter salary data. Most workers in this role earn between $42,500.00 and $60,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in Medical Device Development, and why are they important?

To thrive in Medical Device Development, you need expertise in engineering or life sciences, a solid understanding of regulatory requirements, and often an advanced degree such as a master's or Ph.D. in a relevant field. Familiarity with CAD software, prototyping tools, and knowledge of FDA or ISO regulatory standards is typically required. Strong problem-solving abilities, collaboration, and effective communication distinguish top professionals in this field. These skills ensure the development of safe, innovative, and compliant medical devices that meet both user needs and regulatory standards.

What is the difference between Medical Device Development vs Medical Device Quality Assurance?

AspectMedical Device DevelopmentMedical Device Quality Assurance
CredentialsEngineering degrees, certifications like RAPS or regulatory trainingQuality certifications, ISO 13485, regulatory compliance training
Work EnvironmentDesign labs, R&D teams, product development settingsManufacturing sites, quality control labs, compliance departments
Industry UsageDesigning and creating new medical devicesEnsuring devices meet quality and regulatory standards

Medical Device Development focuses on designing and creating new medical devices, involving engineering and product innovation. Medical Device Quality Assurance ensures these devices meet safety, quality, and regulatory standards through testing and compliance processes. Both roles are essential in the medical device industry but serve different functions in the product lifecycle.

What are some common challenges faced by professionals in medical device development, and how can they be addressed?

Professionals in medical device development frequently encounter challenges such as navigating complex regulatory requirements, ensuring product safety and efficacy, and managing cross-functional collaboration between engineering, clinical, and regulatory teams. Addressing these challenges requires staying updated on evolving regulations, fostering open communication among diverse team members, and implementing robust quality control processes. Proactively engaging with regulatory bodies and regularly reviewing project milestones can help streamline development and reduce the risk of costly delays.

What is medical device development?

Medical device development is the process of designing, creating, testing, and bringing medical devices to market. This process involves multiple stages, including concept development, prototyping, preclinical and clinical testing, regulatory approval, and manufacturing. The goal is to ensure that new devices are safe, effective, and meet regulatory standards before they are used by healthcare professionals or patients. Teams in medical device development often include engineers, scientists, regulatory specialists, and quality assurance professionals.
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What states have the most Medical Device Development jobs? States with the most job openings for Medical Device Development jobs include:
What job categories do people searching Medical Device Development jobs look for? The top searched job categories for Medical Device Development jobs are:
Medical Device Development jobs near you

Agile Program Lead / Principal Software Engineer - Medical Device Development

Suntra MedTech Solutions

Bedford, NH

Other

Posted 23 days ago

Job description

Description

 We are accepting resumes for an experienced software engineer operating as a Product Owner / Scrum Master to serve as the connective tissue between technical development teams (software, firmware, systems, cybersecurity, electronics, mechanical, test) and the Program Manager responsible for overall product delivery. This role ensures that requirements are clearly defined, prioritized, and executed using agile practices-while maintaining compliance with medical device regulatory standards.

The ideal candidate understands both agile product delivery and regulated medical device development and can enable the team to benefit from an agile development process while ensuring that program-level objectives are met.


Responsibilities

Product Ownership & Backlog Management

  • Own and manage the product backlog, ensuring alignment with program milestones, regulatory requirements, and customer needs
  • Translate program-level requirements, system requirements, and user needs into clear, well-defined user stories and acceptance criteria
  • Prioritize backlog items based on risk, regulatory impact, value, and delivery timelines
  • Ensure traceability between user needs, system/software requirements, implementation, and verification activities

Scrum Master & Agile Execution

  • Serve as Scrum Master for one or more multi-disciplinary development teams
  • Facilitate agile ceremonies: backlog grooming, sprint planning, standups, sprint reviews, and retrospectives
  • Remove impediments and proactively manage dependencies across teams
  • Coach teams on agile best practices within a regulated development environment

Program & Stakeholder Interface

  • Act as the primary liaison between the technical team and Program Manager
  • Ensure development work aligns with program schedules, deliverables, and risk management plans
  • Communicate progress, risks, and tradeoffs clearly to program leadership and stakeholders
  • Support cross-functional coordination with Quality, Regulatory Affairs, Clinical, and Cybersecurity teams

Regulatory & Quality Alignment

  • Ensure agile artifacts support design controls, including documentation, traceability, and verification planning
  • Work within ISO 13485, IEC 62304, IEC 62366, and FDA design control requirements
  • Partner with Quality and Regulatory teams to ensure backlog items and increments are audit-ready
  • Support cybersecurity, safety, and risk management activities as part of product development

Requirements

Required Qualifications

  • Bachelor's Degree and 5+ years industry experience, with 2+ years in product ownership, scrum mastery, or technical program delivery
  • Hybrid environment but must be flexible and willing to work onsite for a minimum of 3 days per week
  • Experience working in medical device or other regulated product development environments
  • Strong understanding of Agile/Scrum frameworks and practical application in regulated settings
  • Ability to translate complex technical and regulatory requirements into actionable development work
  • Excellent communication skills across technical, quality, and executive stakeholders
  • Experience with development of software, firmware, or connected medical devices

Preferred Qualifications

  • Familiarity with FDA submissions (510(k), De Novo, PMA) and design history files (DHF)
  • Knowledge of cybersecurity for medical devices and secure product development
  • Experience working closely with Program Managers on multi-disciplinary development programs
  • Certified Scrum Master (CSM), SAFe, or Product Owner certification

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