ZipRecruiter

Log In

1

Medical Device Product Development Engineer Jobs in Boston, MA

Hologic

R&D Engineer 2

Marlborough, MA · On-site

The ideal candidate will have experience in medical device product development and sustaining engineering, with strong skills in CAD design, data analysis, engineering testing, root cause ...

Hologic Inc.

R&D Engineer 2

Marlborough, MA · On-site

The ideal candidate will have experience in medical device product development and sustaining engineering, with strong skills in CAD design, data analysis, engineering testing, root cause ...

Jj

Product Software Development, Staff QE

Boston, MA · On-site

Job Function: R&D Product Development Job Sub Function: R&D Software/Systems Engineering Job ... medical device software systems. The Staff Quality Engineer will be the subject matter expert in ...

Socket.dev

Staff Design Quality Engineer

Burlington, MA · On-site

$150 - $200/hr

The Staff Design Quality Engineer is responsible for supporting new hardware and software medical device product development, sustaining product line activities, and hardware customer quality ...

Nova Biomedical

Software Engineer Manager

Norwood, MA · On-site

The Software Engineer Manager will also help bring biotechnology software development capabilities ... Manage software development activities throughout the complete medical device product lifecycle ...

next page

Showing results 1-20

All JobsMedical Device Product Development Engineer JobsMedical Device Product Development Engineer Jobs in Boston, MA

Medical Device Product Development Engineer information

See Boston, MA salary details

$42.9K

$95.5K

$143.9K

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

As of Sep 8, 2026, the average yearly pay for medical device product development engineer in Boston, MA is $95,472.00, according to ZipRecruiter salary data. Most workers in this role earn between $78,200.00 and $108,600.00 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 are popular job titles related to Medical Device Product Development Engineer jobs in Boston, MA?

For Medical Device Product Development Engineer jobs in Boston, MA, the most frequently searched job titles are:

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:

Medical Device Product Development Engineer jobs near you
Infographic showing various Medical Device Product Development Engineer job openings in Boston, MA as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution, with an average salary of $95,472 per year, or $45.9 per hour.

R&D Engineer 2

Hologic

Marlborough, MA • On-site

Full-time

Posted 10 days ago

Hologic rating

8.0

Company rating: 8.0 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

182nd of 499 rated machine equipment manufacturers

Job description


Job Summary:
We are seeking a highly motivated R&D Engineer, Sustaining to support lifecycle management activities for Hologic medical devices. This role is responsible for driving product improvements, design changes, technical investigations, verification testing, documentation updates, and continuous improvement initiatives to ensure products continue to meet performance, quality, regulatory, and customer requirements throughout their lifecycle.
The ideal candidate will have experience in medical device product development and sustaining engineering, with strong skills in CAD design, data analysis, engineering testing, root cause investigation, and quality system processes. This individual will work closely with cross-functional teams including Quality, Manufacturing, Regulatory Affairs, Clinical Affairs, and Operations to resolve technical challenges, implement product enhancements, and support the ongoing reliability, compliance, and performance of released products.
Essential Duties and Responsibilities:
The incumbent may be asked to perform other function-related activities in addition to the below mentioned as responsibilities as reasonably required by business needs.
  • Support sustaining R&D activities for Hologic products throughout the product lifecycle, including product enhancements, design changes, obsolescence management, reliability improvements, and cost optimization initiatives.
  • Investigate complex product, manufacturing, and field-related issues; perform root cause analyses and recommend effective corrective and preventive engineering solutions.
  • Develop, coordinate, and execute engineering studies, verification testing, and product evaluations to support design changes, issue resolution, and continuous improvement efforts.
  • Analyze and interpret technical data, test results, customer feedback, and field performance metrics to drive data-based engineering decisions.
  • Translate customer, clinical, manufacturing, quality, regulatory, and business needs into engineering requirements, design updates, technical specifications, and controlled documentation.
  • Prepare and communicate technical reports, engineering assessments, risk evaluations, and recommendations to technical teams, management, and cross-functional stakeholders.
  • Plan, manage, and document sustaining engineering projects, including scope, deliverables, schedules, risks, and resource requirements; adjust plans as priorities evolve.
  • Evaluate the feasibility, reliability, and compliance impact of proposed product changes, components, tooling, fixtures, software updates, and manufacturing process improvements.
  • Partner closely with Quality, Manufacturing, Regulatory Affairs, Clinical Affairs, Supply Chain, Service, Marketing, and Operations teams to ensure successful implementation of product and process changes.
  • Drive cross-functional alignment, decision-making, and execution to meet project objectives, compliance requirements, and business commitments with minimal supervision.
  • Interface with manufacturing operations, suppliers, contract manufacturers, and internal stakeholders to gather feedback, resolve technical concerns, and support product performance in the field.
  • Support regulatory submissions, audits, complaint investigations, CAPA activities, risk management efforts, and design control requirements as needed.

Qualifications
Education:
  • Bachelor's degree in Mechanical Engineering, Electrical Engineering, or a related engineering field.
  • Minimum of 2 years of engineering experience in the medical device industry or another highly regulated environment.
  • Experience with medical device development engineering or biomedical engineering design activities.
  • Experience with CAD tools, including SolidWorks, and Altium Designer.
  • Hands-on prototyping and troubleshooting experience, including 3D printing, machining, soldering, and laboratory skills.
  • Experience supporting released products through design changes, product improvements, root cause investigations, verification testing, and engineering change processes.
  • Proven ability to analyze technical data, evaluate design and process alternatives, and develop effective solutions to complex product and manufacturing challenges.
  • Experience working within medical device quality systems and design controls, including CAPA, risk management, change management, and regulatory compliance activities.
  • Demonstrated success collaborating with cross-functional teams including Quality, Manufacturing, Regulatory Affairs, Clinical Affairs, and Operations to execute projects and drive business objectives.

Experience:
Skills:
Preferred skills
  • Experience supporting capital equipment in a sustaining engineering role.
  • Experience with sustaining engineering, post-market product support, or product lifecycle management within the medical device industry.
  • Familiarity with FDA Quality System Regulations, and design control requirements.
  • Experience supporting complaint investigations, CAPA activities, risk assessments, verification testing, and regulatory submissions.
  • Experience working with electromechanical systems, disposable medical devices, or diagnostic products.
  • Prior experience mentoring junior engineers or leading cross-functional technical initiatives

So why join Hologic?
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.
If you have the right skills and experience and want to join our team, apply today. We can't wait to hear from you!
The annualized base salary range for this role is $78,000 - $122,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
As part of our commitment to a fair and accurate evaluation of each candidate's qualifications, we require all applicants to refrain from using AI tools, such as generative AI or automated writing assistance, during any stage of the interview process. Responses influenced by AI may result in disqualification. We appreciate your understanding and cooperation in ensuring a transparent and equitable selection process.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
#LI-RT1

What Hologic employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom

Apply