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Medical Device Product Development Engineer Jobs in Boston, MA

Medical Device * Class II+ Medical Device * Product Development Lifecycle * Regulatory Compliance * Human Factors Engineering Tools & Technologies * Agile Tools * User-Experience Research Tools

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Medical Device Product Development Engineer information

See Boston, MA salary details

$43K

$95.7K

$144.3K

How much do medical device product development engineer jobs pay per year?

As of Aug 19, 2026, the average yearly pay for medical device product development engineer in Boston, MA is $95,736.00, according to ZipRecruiter salary data. Most workers in this role earn between $78,400.00 and $108,900.00 per year, depending on experience, location, and employer.

What does a medical device product development engineer do?

A Medical Device Product Development Engineer is responsible for designing, developing, and testing medical devices to ensure they are safe, effective, and compliant with regulatory standards. They work closely with cross-functional teams, including quality assurance, regulatory affairs, and manufacturing, to take products from concept through to production. Their tasks often include prototyping, risk assessment, documentation, and troubleshooting any issues that arise during the development process. Additionally, they must stay updated on industry standards and regulations to ensure that products meet all necessary requirements for market approval.

What are the key skills and qualifications needed to thrive as a medical device product development engineer?

To thrive as a Medical Device Product Development Engineer, you need a strong background in biomedical, mechanical, or electrical engineering, along with knowledge of FDA regulations and product development processes. Familiarity with CAD software, prototyping tools, risk management systems, and regulatory standards such as ISO 13485 is typically required. Creativity, problem-solving, and effective teamwork are essential soft skills that drive innovation and ensure project success. These skills and qualifications are crucial for developing safe, effective medical devices that meet strict regulatory requirements and address real-world healthcare needs.

What are some common challenges medical device product development engineers face when working on new product designs?

Medical Device Product Development Engineers often navigate strict regulatory requirements and rigorous testing protocols to ensure product safety and compliance. Balancing innovative design with manufacturability and cost constraints can be challenging, as can coordinating input from cross-functional teams such as clinical, regulatory, and manufacturing. Additionally, managing project timelines while accommodating iterative design changes based on feedback or testing results requires strong organizational and communication skills.

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

AspectMedical Device Product Development EngineerQuality Assurance Engineer
CredentialsEngineering degree, certifications like PMP or Six Sigma often preferredEngineering or science degree, certifications like CQE or ISO auditor training
Work EnvironmentDesign labs, R&D departments, cross-functional teamsManufacturing facilities, quality control labs, compliance departments
Industry UsageInvolved in designing and developing new medical devicesEnsures products meet quality standards and regulatory requirements

While both roles are essential in the medical device industry, the Medical Device Product Development Engineer focuses on creating and improving devices, whereas the Quality Assurance Engineer ensures these devices meet safety and quality standards. Understanding these differences helps in choosing the right career path or job search focus.

What job categories do people searching Medical Device Product Development Engineer jobs in Boston, MA look for?

The top searched job categories for Medical Device Product Development Engineer jobs in Boston, MA are:

Infographic showing various Medical Device Product Development Engineer job openings in Boston, MA as of August 2026, with employment types broken down into 33% Full Time, and 67% Contract. Highlights an 100% In-person job distribution, with an average salary of $95,736 per year, or $46 per hour.

Senior Biomedical Mechanical Design Engineer Disposable IVD

Haemonetics Software Solutions

Boston, MA • On-site

$78.40 - $133.40/hr

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Job description

Haemonetics Software Solutions in Boston is looking for a Senior Biomedical Product Development Engineer to oversee mechanical design for disposable components within the TEG6s IVD system. This role involves leading the complete lifecycle of device components and collaborating closely with cross-functional teams to ensure robust product performance.

Ideal candidates should hold a Bachelor’s degree in Bioengineering or Mechanical Engineering, with a minimum of 5 years in medical device product development. Competitive salary ranges from $78,400 to $133,400 annually, along with extensive benefits.

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