ZipRecruiter

Log In

1

Medical Device Designer Jobs (NOW HIRING)

BSI Group

Medical Device QMS Auditor

Concord, NC · Remote

$98K - $123K/yr

Minimum of 4 years' experience in the medical device, SaMD, or IVD fields with direct, hands-on involvement in designing, manufacturing, validating, inspecting, testing, or clinically evaluating ...

Merck & Co.

... or medical device industries to set tactical and strategic direction on programs they lead to ... Serve as key point-of-contact with potential external device designers, developers, and suppliers ...

next page

Showing results 1-20

All JobsMedical Device Designer Jobs

Medical Device Designer information

See salary details

$75.5K

$128.3K

$188K

How much do medical device designer jobs pay per year?

As of Jul 22, 2026, the average yearly pay for medical device designer in the United States is $128,257.00, according to ZipRecruiter salary data. Most workers in this role earn between $110,000.00 and $144,000.00 per year, depending on experience, location, and employer.

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

To thrive as a Medical Device Designer, you need a strong background in biomedical engineering, product design, and knowledge of regulatory standards, typically supported by a relevant engineering degree. Proficiency with CAD software, rapid prototyping tools, and familiarity with FDA or ISO regulatory systems is essential. Creativity, problem-solving, collaboration, and attention to detail are vital soft skills for innovating and ensuring safety in device development. These skills and qualities are crucial for creating effective, compliant, and user-friendly medical devices that improve patient outcomes and meet industry standards.

What does a Medical Device Designer do?

A Medical Device Designer is responsible for creating and developing medical devices and equipment used in healthcare settings. They combine knowledge of engineering, biology, and design principles to ensure products are safe, effective, and user-friendly. Their role involves working closely with healthcare professionals, conducting research, prototyping, and adhering to regulatory standards throughout the design and development process. Medical Device Designers help bring innovative medical solutions to market that improve patient care and outcomes.

What are some common challenges faced by medical device designers when balancing innovation with regulatory compliance?

Medical device designers often face the challenge of creating innovative, user-friendly products while ensuring strict adherence to regulatory standards such as FDA or ISO requirements. Balancing creativity with compliance can be demanding, as any design change may necessitate additional documentation, testing, and validation. Designers must closely collaborate with regulatory specialists, engineers, and clinicians to ensure their solutions are both safe and effective. Staying up-to-date with changing regulations and incorporating feedback from multidisciplinary teams are key aspects of overcoming these challenges.
More about Medical Device Designer jobs
What cities are hiring for Medical Device Designer jobs? Cities with the most Medical Device Designer job openings:
What states have the most Medical Device Designer jobs? States with the most job openings for Medical Device Designer jobs include:
What job categories do people searching Medical Device Designer jobs look for? The top searched job categories for Medical Device Designer jobs are:
Medical Device Designer jobs near you
Infographic showing various Medical Device Designer job openings in the United States as of July 2026, with employment types broken down into 88% Full Time, 7% Part Time, 1% Temporary, and 4% Contract. Highlights an 88% Physical, 6% Hybrid, and 6% Remote job distribution, with an average salary of $128,257 per year, or $61.7 per hour.

Medical Device QMS Auditor

The British Standards Institution (BSI)

Reston, VA • On-site

$98K - $123K/yr

Full-time

Medical, Dental, Life, Retirement, PTO

Posted 2 days ago

Job description

We exist to create positive change for people and the planet. Join us and make a difference too!
Job Title: Medical Device QMS Auditor
Location: Candidates must reside in one of the following states: IL, MN, WI, IN, NJ, MA, PA, OH.
BSI (British Standards Institution) is the global business standards company that equips businesses with the solutions to turn standards of best practice into habits of excellence.
Our Medical Devices (or Regulatory Services) team ensures patient safety while supporting timely market access for our clients' medical device products globally. BSI is an accredited ISO 13485 Certification Body recognized in many global markets.
This is a travel based position with extensive travel to medical device manufacutering sites. Candidate must be comfortable with overnight travel of 13-15 days out of every month.
Essential Responsibilities
  • Analyze and assess quality management systems with emphasis on design controls, manufacturing controls, production processes, process validation, verification/validation, and testing activities, ensuring compliance with ISO 13485, CE Marking, and MDSAP schemes.
  • Assess manufacturing processes including production controls, process validation, risk management, supplier controls, and design transfer activities.
  • Prepare assessment reports and communicate findings to clients, providing clear direction for corrective actions where appropriate.
  • Recommend the issue, re-issue, or withdrawal of certificates in accordance with BSI policies and procedures.
  • Lead assessment teams, ensuring quality of service and effective working relationships with clients and team members.

Education & Technical Qualifications
  • Technical degree (Bachelor's, or higher) in Engineering, Science, or a related technical discipline required. Relevant fields include Biomedical, Mechanical, Electrical, or Chemical Engineering; Materials Science; Biology; Microbiology; Chemistry; or related technical fields applicable to medical devices, SaMDs, or IVDs.
  • Minimum of 4 years' experience in the medical device, SaMD, or IVD fields with direct, hands-on involvement in designing, manufacturing, validating, inspecting, testing, or clinically evaluating devices. Candidates must have personally worked with devices, specifications, or code, indicate the types and classifications of devices, and demonstrate their level of involvement on their CV. Regulatory or audit experience only is insufficient.
  • Detailed hands-on experience with design and manufacturing/production controls, including process validation (IQ/OQ/PQ), risk management, supplier controls, CAPA, nonconforming product management, and change control.
  • Knowledge of regulatory requirements and quality management standards including ISO 13485, MDSAP, FDA QSR (21 CFR 820), and EU MDR/IVDR are a plus

Core Competencies
  • Strong verbal and written communication skills, and attention to detail.
  • Ability to work under pressure and meet deadlines.
  • Self-motivated, flexible, and excellent time management/planning skills.
  • Willingness to travel extensively.
  • Enthusiastic, committed team player.
  • Business development and public speaking skills are considered advantageous.

Preferred Qualifications
  • Experience with process validation, equipment qualification, and manufacturing process development.
  • Experience in design and development activities, including design controls and design transfer.
  • Hands-on experience with software-controlled medical devices, SaMD, or automated manufacturing systems.
  • Experience auditing or assessing quality management systems compliant with ISO 13485, CE Marking, and MDSAP.
  • Experience with risk management (ISO 14971), sterile medical devices, aseptic processing, or cleanroom manufacturing.
  • Experience leading hands-on teams in manufacturing, testing, or validation.
  • Lead Auditor certification (ISO 13485, MDSAP, or equivalent) preferred.
  • Previous experience working for a Notified Body, Regulatory Body, or Certification Body preferred.
  • Advanced degree (MS, PhD) in engineering, science, or related technical discipline preferred.

The salary for this position can range from $98,100 to $123,860 annually; actual compensation is based on various factors, including but not limited to, the candidate's competencies, level of experience, education, location, divisional budget and internal peer compensation comparisons. BSI offers a competitive salary, group-sponsored health and dental, short-term and long-term disability, a company-matched 401k plan, company paid life insurance, 11 paid holidays and 4 weeks paid time off.
#LI-REMOTE
#LI-MS1
About Us
BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives.
Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments.
Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs.
Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society's critical issues - from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world.
BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.

Apply