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Medical Device Design Jobs (NOW HIRING)

aspensurgical

Sr Design Engineer

Caledonia, MI

Execute medical device design history file activities to be compliant with applicable regulations * Conduct the development and evaluation of medical device designs which meet defined product ...

Aspen Surgical

Sr Design Engineer

Caledonia, MI · On-site

Execute medical device design history file activities to be compliant with applicable regulations * Conduct the development and evaluation of medical device designs which meet defined product ...

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How much do medical device design jobs pay per hour?

As of Jun 30, 2026, the average hourly pay for medical device design in the United States is $49.84, according to ZipRecruiter salary data. Most workers in this role earn between $35.10 and $59.62 per hour, depending on experience, location, and employer.

What is a Medical Device Design job?

A Medical Device Design job involves creating, developing, and improving medical devices to ensure they are safe, effective, and user-friendly. Professionals in this field work with engineers, regulatory specialists, and healthcare professionals to meet industry standards and patient needs. They use computer-aided design (CAD) software, prototyping, and testing methodologies to refine devices before production. The role requires knowledge of biomechanics, materials science, and regulatory guidelines such as FDA and ISO standards.

What are some typical challenges faced in a Medical Device Design role?

Medical Device Design professionals often encounter challenges such as balancing innovative design with stringent regulatory requirements and ensuring devices are both effective and safe for patient use. Navigating complex approval processes, collaborating with clinicians for feedback, and keeping up with rapidly evolving technologies can also be demanding. However, these challenges make the role dynamic and rewarding, as designers play a direct role in improving patient outcomes. Team-based problem solving and ongoing learning are key parts of the job, and successfully overcoming challenges can lead to career growth and leadership opportunities within the medical device industry.

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

Success in Medical Device Design requires a solid understanding of biomedical engineering, materials science, and human anatomy, often supported by a relevant engineering degree and experience in product development. Familiarity with CAD software, rapid prototyping tools, and regulatory standards such as FDA or ISO 13485 certification is common in the field. Strong problem-solving abilities, teamwork, and effective communication help professionals excel in multidisciplinary design teams. These competencies are crucial for creating safe, innovative medical devices that meet strict quality and regulatory requirements.

More about Medical Device Design jobs
What cities are hiring for Medical Device Design jobs? Cities with the most Medical Device Design job openings:
What are the most commonly searched types of Medical Device Design jobs? The most popular types of Medical Device Design jobs are:
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Medical Device Design jobs near you
Infographic showing various Medical Device Design job openings in the United States as of June 2026, with employment types broken down into 1% Locum Tenens, 67% Full Time, 6% Part Time, and 26% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $103,662 per year, or $49.8 per hour.
Medical Device Design Quality Engineer

Medical Device Design Quality Engineer

Conflux Systems

Newton, MA • On-site

Full-time

Posted 12 days ago

Job description

No C2C / Only W2 / No Sponsership
Seeking an experienced Senior Design Quality Engineer to support development of complex robotic and electromechanical Class III medical systems. This role leads Design Controls, risk management, and V&V quality oversight to ensure regulatory compliance and robust product realization across the lifecycle.
Responsibilities:
  • Serve as Quality representative and Design Controls lead on cross-functional teams.
  • Ensure compliance with FDA QSR (21 CFR 820.30), ISO 13485, MDR/MDD, and global regulations.
  • Lead risk management per ISO 14971, including system-level risk analysis, FMEA/SWFMEA, and residual risk evaluation.
  • Maintain end-to-end traceability between design inputs/outputs, risk controls, and verification & validation (V&V).
  • Review/approve V&V protocols and reports; support tolerance, worst-case, and margin analyses.
  • Support IEC 60601-1, IEC 60601-1-2, IEC 80601-2-77 electrical safety/EMC compliance.
  • Collaborate on HW/SW integration and ensure compliance with IEC 62304/82304.
  • Support supplier qualification, design transfer, and DHF completeness.
  • Contribute to IDE, De Novo, PMA submissions.
  • Lead CAPA, NCMR, complaint investigations, and root cause analysis.

Qualifications:
  • Bachelor's degree in Engineering, Biomedical Engineering, or Life Sciences.
  • 7-10 years' experience in Design Quality within medical devices (Class III preferred).
  • Strong knowledge of Design Controls, QSR, ISO 13485, ISO 14971.
  • Experience with Minitab or statistical analysis tools.
  • Familiarity with ESD controls, electrical components handling.
  • Strong technical writing, communication, and time management skills.

Apply