To hire a medical device engineer, first decide which kind you need: a design (R&D) engineer, a quality engineer, a manufacturing or process engineer, a regulatory-facing engineer, or a software engineer building software as a medical device (SaMD).
Then screen for hands-on work under FDA design controls (21 CFR Part 820, now the Quality Management System Regulation aligned with ISO 13485), ISO 14971 risk management and verification and validation, not just a biomedical degree.
Budget around the BLS median of $109,370 for bioengineers and biomedical engineers (May 2025). Source from device companies, contract manufacturers and adjacent regulated industries, and test candidates with real design history file and risk file scenarios.
Key takeaways
- “Medical device engineer” covers at least five different jobs. Write the posting for one of them, not all five.
- FDA’s Quality Management System Regulation (QMSR) took effect February 2, 2026, and incorporates ISO 13485:2016 by reference. Candidates should be able to explain what changed from the old QSR.
- BLS reports a May 2025 median wage of $109,370 for bioengineers and biomedical engineers, with the top 10 percent above $168,180.
- The strongest signal is documented work: design inputs and outputs, trace matrices, risk files, protocols and reports the candidate personally wrote.
- Many great hires come from mechanical, electrical and software backgrounds in other regulated industries, not only from biomedical engineering programs.
What does a medical device engineer do, and which type do you need?
A medical device engineer designs, tests, manufactures or maintains devices that diagnose, treat or monitor patients, and does it inside a documented quality system. The O*NET profile for bioengineers and biomedical engineers lists tasks such as evaluating the safety and effectiveness of equipment, preparing documents for regulatory submissions, and writing qualification and validation reports with manufacturing and quality staff. In practice, the title splits into distinct roles.
| Variant | What they do | Typical background |
|---|---|---|
| R&D / design engineer | Turns user needs into design inputs, builds prototypes, runs design reviews, owns design outputs and the design history file (DHF) | BS/MS in mechanical, biomedical or electrical engineering; CAD (SolidWorks, Creo); tolerance analysis |
| Quality engineer (design or supplier quality) | Runs CAPA, nonconformance, complaint investigations, risk management files, audits and supplier qualification | Engineering degree plus QMS experience; ASQ certifications are common |
| Manufacturing / process engineer | Transfers designs to production, writes IQ/OQ/PQ protocols, validates processes such as molding, sealing and sterilization, improves yield | Mechanical, industrial or manufacturing engineering; cleanroom and lean experience |
| Regulatory-facing engineer | Builds technical content for 510(k), De Novo or PMA submissions, maps standards, answers FDA questions | Engineering degree plus submission experience; RAC-Devices credential is a plus |
| Software engineer (SaMD / SiMD) | Develops device software under IEC 62304, maintains software documentation, handles cybersecurity and anomaly tracking | Computer science or computer/electrical engineering; embedded C/C++ or cloud and mobile stacks |
If you are building a team from scratch, the first engineer is usually a design engineer who can also run early risk management. As you get closer to a submission and production, quality and process engineers matter more. For a deeper look at the career side of the field, see our post on whether biomedical engineering is a good career, and for the quality function specifically, what a quality engineer does.
What skills and certifications should you require?
The regulatory baseline has shifted. FDA’s Quality Management System Regulation became effective February 2, 2026. It amends 21 CFR Part 820 and incorporates ISO 13485:2016 by reference, and FDA inspections now follow compliance program 7382.850. Engineers who have worked only under the older Quality System Regulation still have useful design control skills, but they should understand the ISO 13485 structure and vocabulary your auditors will use.
| Required (most roles) | Preferred / role-specific |
|---|---|
| Bachelor’s degree in biomedical, mechanical, electrical or a related engineering field | MS for R&D roles on complex or active implantable devices |
| Working knowledge of design controls: user needs, design inputs and outputs, reviews, verification, validation, design transfer, DHF | Experience supporting a 510(k), De Novo or PMA through to clearance or approval |
| Risk management under ISO 14971:2019: hazard analysis, FMEA, risk controls, benefit-risk | Usability engineering (IEC 62366-1) and human factors testing |
| Writing test protocols and reports with statistical rationale for sample sizes | IEC 60601-1 electrical safety and IEC 60601-1-2 EMC testing for powered devices |
| Good documentation practices and change control in a QMS | IEC 62304 software life cycle and FDA cybersecurity expectations for software roles |
| Root cause analysis and CAPA basics | Process validation (IQ/OQ/PQ), sterilization and biocompatibility (ISO 10993) for manufacturing roles |
| CAD or the core tools of the discipline (SolidWorks, Creo, Altium, MATLAB, embedded C) | ASQ Certified Quality Engineer, ASQ Certified Medical Device Auditor, or RAPS RAC-Devices |
A PE license is rarely required in device product development, because engineers are not selling services directly to the public. If you are unsure whether a role needs one, our guide on PE vs EIT vs no license covers when it matters.
Recruiter tip: Ask for device class and pathway on every resume screen. An engineer from a Class III implant program under PMA and one from a Class I accessory company can both say “design controls,” but the rigor behind the words is very different. Match the candidate’s history to your device class and regulatory path.
How much does it cost to hire a medical device engineer?
BLS does not track “medical device engineer” as its own occupation. The closest benchmark is bioengineers and biomedical engineers (SOC 17-2031). Because many device design and manufacturing engineers are mechanical engineers by training, mechanical engineers (SOC 17-2141) are shown as a second reference point. Both figures are national wages from the May 2025 Occupational Employment and Wage Statistics survey and do not include bonus, equity or benefits.
| Occupation (BLS proxy) | 10th percentile | Median | 90th percentile |
|---|---|---|---|
| Bioengineers and biomedical engineers (primary benchmark) | $71,850 | $109,370 | $168,180 |
| Mechanical engineers (secondary benchmark) | $73,990 | $104,110 | $164,340 |
Industry matters. BLS reports that in May 2025 the median wage for bioengineers and biomedical engineers was $107,550 in medical equipment and supplies manufacturing and $130,340 in navigational, measuring, electromedical and control instruments manufacturing. If you build powered or electronic devices, expect to compete against that higher band.
| Industry | Median annual wage, bioengineers and biomedical engineers |
|---|---|
| Navigational, measuring, electromedical and control instruments manufacturing | $130,340 |
| Research and development in the physical, engineering and life sciences | $125,160 |
| Medical equipment and supplies manufacturing | $107,550 |
| Healthcare and social assistance | $103,170 |
The talent pool is small. BLS counts 23,800 bioengineer and biomedical engineer jobs in 2025 and projects about 1,200 openings a year from 2025 to 2035, with employment growing 8 percent. That is one reason many device companies also recruit from mechanical, electrical and software engineering. For short validation pushes, submission crunches or remediation projects, contract engineers can fill the gap; our breakdown of contract staffing vs direct hire explains the trade-offs.
Where do you find medical device engineers?
- Professional associations. BMES (Biomedical Engineering Society) for R&D and early career talent, AAMI for engineers working in standards, sterilization and QMSR training, RAPS for regulatory-facing engineers, and ASQ sections for quality engineers.
- University programs with device co-ops. BLS notes that biomedical engineering students often do co-ops or internships with hospitals and device manufacturers. Senior design showcases and capstone sponsors are a low-cost pipeline for entry-level design engineers.
- Contract manufacturers and component suppliers. Engineers at contract manufacturing organizations, molders, extruders and sterilization providers often know process validation and design transfer better than OEM staff.
- Adjacent regulated industries. Aerospace (AS9100), automotive (IATF 16949 and functional safety) and pharmaceutical manufacturing produce engineers used to traceability, validation and audits. They need training on ISO 14971 and device-specific rules, but the habits transfer.
- Hospital clinical engineering departments. Clinical engineers understand how devices fail in real use, which makes them strong candidates for complaint handling, post-market and human factors roles.
- Former employees of acquired or shut-down device startups. Startup engineers often wore several hats, from prototype through first submission, and are used to building quality systems from nothing.
For manufacturing-side roles, our posts on what a process engineer does and manufacturing engineering careers describe the backgrounds that transfer well.
How do you write the job description?
Name the device, the class and the stage of the product. Strong candidates choose roles based on whether they will design, transfer, sustain or remediate. Use this template and adjust it for the variant you picked. Our guide on how to write a great job posting covers titles, pay ranges and ATS keywords.
Job description template: [Design / Quality / Process / Software] Engineer, Medical Devices
About the role: [Company] develops [device type], a Class [I / II / III] device cleared or approved through [510(k) / De Novo / PMA]. You will [design new products / transfer designs to manufacturing / sustain released products / build device software] as part of a [#]-person engineering team in [City, State / hybrid].
What you will do:
- Own [design inputs and outputs / risk management file / process validations / software requirements] under our ISO 13485 and FDA QMSR quality system
- Write and execute verification and validation protocols and reports
- Maintain ISO 14971 risk documentation, including [FMEA / hazard analysis]
- Support [design reviews / CAPA / supplier qualification / regulatory submissions]
What you bring: BS in [biomedical / mechanical / electrical / software] engineering; [#]+ years in a regulated medical device environment; hands-on experience with [SolidWorks / IEC 60601 testing / IEC 62304 / IQ-OQ-PQ]. Preferred: [ASQ CQE / RAC-Devices / MS degree].
Pay and benefits: $[range] base, [bonus / equity], [benefits]. [Travel %] travel to [suppliers / clinical sites].
What interview questions should you ask?
Ask questions that force the candidate to walk through documents they actually produced. Generic questions about teamwork will not separate someone who wrote a risk file from someone who signed one. For general and behavioral questions, see our list of questions to ask an interviewee.
- “Walk me through one design input you wrote and how you verified it.” Listen for a measurable, testable requirement, a traced test method and a sample size with a reason behind it.
- “What is the difference between design verification and design validation on your last project?” Strong answers tie verification to design inputs and validation to user needs under actual or simulated use conditions.
- “Describe a hazard you identified under ISO 14971 and the risk control you chose.” Look for the order of controls (inherent safety by design first, then protective measures, then information for safety) and how they confirmed the control worked.
- “What changed for your team when FDA moved from the QSR to the QMSR?” A current candidate should mention ISO 13485 incorporation by reference and how procedures or terminology were updated.
- “Tell me about a design change after release. How did you decide whether it needed a new submission?” Good answers cover the change assessment, risk impact, regression testing and who signed off.
- For manufacturing roles: “How did you set acceptance criteria for an OQ, and what happened when a run failed?” Look for worst-case parameter challenges and a documented deviation, not a quiet re-run.
- For powered devices: “Which IEC 60601 tests gave you trouble and how did you fix the design?” Real experience sounds like specific failures such as leakage current, creepage distances or EMC emissions.
- For software roles: “How did you assign software safety classification under IEC 62304, and how did it change your documentation?” Listen for the link between classification and the risk analysis, plus how SOUP (third-party software) was handled.
Recruiter tip: Give finalists a short, redacted work sample to review, such as a two-page test protocol with three planted errors (an untestable requirement, a missing acceptance criterion and an unjustified sample size). A 30-minute review tells you more about documentation habits than an hour of conversation.
What red flags should you watch for?
- Uses “verification” and “validation” interchangeably, or cannot say which one ties to user needs.
- Describes risk management as “filling out the FMEA at the end” instead of work that started with the design.
- Lists every standard on the resume (ISO 13485, ISO 14971, IEC 60601, IEC 62304, ISO 10993) but cannot describe a single clause they applied.
- Talks about re-running failed tests until they passed, with no deviation or investigation.
- Has only research lab or academic prototyping experience but is applying for a role that owns design transfer or production.
- Shows no awareness of the QMSR transition in 2026 while claiming current FDA compliance experience.
- Shares confidential design documents from a former employer during the interview. That is a judgment problem, not a portfolio.
Frequently asked questions
Does a medical device engineer need a biomedical engineering degree?
No. BLS notes that bioengineers and biomedical engineers typically need a bachelor’s degree in bioengineering, biomedical engineering or a related engineering field. Mechanical, electrical and software engineers with regulated device experience are often a better fit than a new biomedical graduate, depending on the role.
What is the QMSR and why does it matter for hiring?
The Quality Management System Regulation is FDA’s amended 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 by reference. Engineers who know ISO 13485 well, including those with EU or other international experience, can now apply that knowledge directly to US requirements.
How much does a medical device engineer make?
BLS has no separate medical device engineer category. For the closest benchmark, bioengineers and biomedical engineers, the May 2025 median was $109,370, with the lowest 10 percent under $71,850 and the highest 10 percent above $168,180.
Which certifications are most useful for medical device engineers?
For quality roles, ASQ’s Certified Quality Engineer and Certified Medical Device Auditor are common. For regulatory-facing roles, the RAPS RAC-Devices credential is widely recognized. Design and software roles rely more on demonstrated experience with design controls, ISO 14971 and IEC 62304 than on certifications.
Should I hire a contract or full-time medical device engineer?
Contract engineers work well for defined projects such as a verification campaign, a process validation backlog or submission support. Full-time hires make more sense for design ownership and sustaining work, where knowledge of the design history file builds up over years.
Hiring for a regulated device program leaves little room for a wrong fit. Apollo Technical recruits design, quality, manufacturing, regulatory-facing and software engineers for medical device employers. Learn more about our medical device engineering recruitment, or tell us about your open role.
