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Medical Device Risk Management Jobs in Gilbert, AZ

Stryker

Senior Staff Medical Writer (Remote)

Phoenix, AZ · On-site +1

$143K - $238K/yr

Expert knowledge of MEDDEV 2.7/1 Rev. 4, European Union Medical Device Regulation (EU MDR 2017/745 ... Knowledge of clinical operations, risk management, and international regulatory requirements.

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Medical Device Risk Management information

See Gilbert, AZ salary details

$51.3K

$111.2K

$169.5K

How much do medical device risk management jobs pay per year?

As of Sep 11, 2026, the average yearly pay for medical device risk management in Gilbert, AZ is $111,200.00, according to ZipRecruiter salary data. Most workers in this role earn between $89,700.00 and $128,600.00 per year, depending on experience, location, and employer.

What is medical device risk management?

Medical device risk management is the systematic process of identifying, evaluating, and controlling risks associated with medical devices throughout their lifecycle. This process ensures that potential hazards are minimized to protect patient safety and comply with regulatory standards, such as ISO 14971. Risk management includes activities like risk assessment, implementing controls, monitoring, and documenting all steps to demonstrate compliance. It is a critical function in the design, manufacturing, and post-market phases of medical device development.

How does a medical device risk management professional typically collaborate with cross-functional teams during the product development lifecycle?

Medical Device Risk Management professionals work closely with engineering, regulatory affairs, quality assurance, and clinical teams to identify, assess, and mitigate potential risks associated with medical devices. They participate in design reviews, facilitate risk assessments such as FMEA, and ensure that risk controls are effectively implemented and documented according to regulatory standards like ISO 14971. Regular communication and collaboration are essential to align risk management activities with project timelines and compliance requirements, ensuring patient safety and product success.

What are the key skills and qualifications needed to thrive in medical device risk management, and why are they important?

To thrive in Medical Device Risk Management, you need a solid background in engineering or life sciences, a thorough understanding of regulatory standards (such as ISO 14971), and experience in risk assessment processes. Familiarity with risk management software, quality management systems, and relevant regulatory databases is typically required, along with certifications like Certified Risk Manager (CRM) or RAC. Strong analytical thinking, attention to detail, and effective communication are crucial soft skills for evaluating risks and collaborating with cross-functional teams. These competencies ensure the safety and compliance of medical devices, protecting both end-users and the company from regulatory or safety issues.

What is the difference between Medical Device Risk Management vs Medical Device Quality Assurance?

AspectMedical Device Risk ManagementMedical Device Quality Assurance
Primary FocusIdentifying, evaluating, and mitigating risks associated with medical devicesEnsuring products meet quality standards and regulatory requirements
CertificationsISO 14971, RAPS certifications often preferredISO 13485, regulatory compliance certifications
Work EnvironmentDesign and development teams, risk analysis meetingsManufacturing, inspection, and quality control departments
Industry UsageUsed throughout product lifecycle for safety managementUsed to maintain product quality and compliance

While both roles are essential in the medical device industry, Risk Management focuses on minimizing safety risks throughout the product lifecycle, whereas Quality Assurance ensures products consistently meet quality and regulatory standards. Understanding these differences helps professionals align their skills with industry needs.

What job categories do people searching Medical Device Risk Management jobs in Gilbert, AZ look for?

The top searched job categories for Medical Device Risk Management jobs in Gilbert, AZ are:

Medical Device Risk Management jobs near you

X-Ray Engineer (Medical Device)

Scottsdale, AZ • On-site

Ziehm Orthoscan
See more jobs at Ziehm Orthoscanexternal

Other

Medical, Dental, Vision, Retirement, PTO

Re-posted 5 days ago

Job description

X-Ray Engineer

Ziehm Imaging - Orthoscan Inc. is currently seeking a motivated, career-oriented professional with a positive can-do attitude to join our team as a full-time X-Ray Engineer located in Scottsdale, AZ.

Why Work for Ziehm Imaging - Orthoscan Inc.? There's something special about Ziehm-Orthoscan. There's a sense of pride that comes from building a product that helps improve people's lives and making the most of ourselves as a company and as individuals. We know the success of Ziehm-Orthoscan depends on every employee in our organization; it is our people who make the difference.

What do we offer?

  • The challenge of meaningful work - we offer constant opportunities to grow and develop world-class skills and a truly rewarding career.
  • A unique culture where people convert their passion into action.
  • The kind of competitive compensation you would expect from a world leader.
  • Nine paid holidays plus a generous PTO and vacation time plan.
  • Great benefit plans, major medical, dental and vision.
  • Company 401(k) plan with an employer match.
  • Competitive salary commensurate with experience
Job Summary

Lead all engineering and production aspects of X-Ray Generation, including electrical high voltage design, glassware, heat management, and lean and quality production processes. Working closely with R&D, QARA, and Production, the X-Ray Engineer serves as the critical technical bridge between engineering design and manufacturing operations, architecting, designing, and developing next-generation X-ray generator assemblies, high-voltage subsystems, high-voltage insulation systems, and oil-filled assemblies from initial engineering concepts through final mass production. Leveraging a strong background in high-voltage testing methodologies and robust manufacturing processes, this role translates research and development concepts into scalable, manufacturable, high-power hardware by applying advanced root-cause analysis and problem-solving techniques. The position also utilizes excellent written and verbal communication skills to develop automated test procedures, manufacturing process documentation, work instructions, validation protocols, and factory acceptance criteria that ensure product quality, clinical reliability, manufacturing efficiency, and strict regulatory compliance.

Essential Functions
  • Own the electrical engineering design, conceptualization, and manufacturing transfer of X-ray generator assemblies, High-Voltage subsystems, High-Voltage insulation systems, and oil-filled assemblies, ensuring sound manufacturing methodologies are engineered directly into the initial layout. Develop technical solutions to achieve marketing/sales requirements to ISO13485 standards
  • Develop, maintain, and improve manufacturing processes, fixtures, work instructions, and acceptance criteria while designing and refining the underlying product architectures
  • Drive reliability improvements for X-ray generator assemblies, High-Voltage subsystems, insulation systems, and oil-filled assemblies by developing, implementing, and executing advanced, physical High-Voltage testing methodologies and validation protocols, ensuring all products are built, tested, and validated to IEC60601-1 4th edition standards
  • Lead data-driven failure analysis, root-cause investigations, corrective actions, and field-return evaluations to implement Engineering Change Orders (ECOs) that directly improve product performance and production yield.
  • Troubleshoot manufacturing, assembly, test, and performance issues related to High-Voltage and X-ray systems, verbally collaborating across R&D, QARA, and Production to deploy rapid, permanent technical solutions.
  • Identify and implement continuous improvement opportunities across processes, work instructions, product quality, and manufacturing efficiency to maintain statistical control of the production line.
  • Own the entire generator technical lifecycle—from incoming parts and assembly processes through burn-in, clinical reliability, and field-return investigations.
Basic Qualifications

Education:

  • Bachelor's degree in Electrical Engineering (BSEE) or a closely related engineering discipline with a strong academic focus in Power Electronics, Electromagnetic Field Theory, or High-Voltage Physics. An advanced Master's degree in Manufacturing Engineering or related disciplines is a plus.
  • 3+ years of progressive electrical or hardware engineering experience designing, developing, validating, and implementing complex high-power or high-voltage (kV-level) electrical systems, with demonstrated expertise in product development and production readiness.
  • 2+ years of progressive electrical engineering experience with demonstrated manufacturing engineering expertise, including manufacturing process development and new product introduction (NPI), is required, preferably in a medical device industry environment.

Experience:

  • High-Voltage testing & process transition experience in engineering or production test engineering (preferably in the medical/industrial X-ray industry), with a proven track record of implementing sound manufacturing processes and safely configuring high-power test benches operating between 40kV and 150kV
  • Structured failure investigation experience leading structured root-cause analysis and problem-solving techniques to dissect generator breakdowns, electrical arcs, and contamination events from factory burn-in failures through clinical field returns.
  • Cross-Functional technical communication: Demonstrated history of utilizing excellent written and verbal communication skills to bridge the gap between R&D, QARA, and Production—specifically transforming complex engineering requirements into audit-ready documentation and manufacturing work instructions.
Competencies
  • Mastery of specialized high-voltage test equipment, including digital oscilloscopes, high-voltage probes, insulation resistance testers, power analyzers, and partial discharge measurement systems
  • Comprehensive knowledge of high-voltage insulation systems, creepage and clearance design, dielectric breakdown, oil insulation systems, electric field management, and vacuum/altitude effects
  • Deep understanding of tube current regulation, filament and anode operation, dark current, tube aging, and tube vacuum behavior.
  • Strong understanding of switching power supplies, resonant converters, inverters, PWM systems, feedback loops, and high-voltage multipliers.
  • Advanced proficiency in evaluating manufacturing processes to maintain strict control, determine process capabilities, design assembly fixtures, and establish compliant process validation (IQ/OQ/PQ) and acceptance criteria
  • Solid understanding of cleanliness and contamination control during assembly, with specific expertise regarding fluid contamination in oil-filled assemblies
  • Application of structured reliability principles and problem-solving techniques to identify root-cause failures, evaluate field returns, and directly improve production yields.
  • Experience in verifying products that meet regulatory/safety standards, using outside test agencies.
  • Keep abreast of new products, trends, and practices within the field/scope of practice as needed
Working Conditions
  • Majority of the work is performed in a manufacturing and office environment.
  • Typical working hours and days are Monday – Friday 7am – 4pm, however this is subject to change depending on work demands
  • Periodic travel may be required (visit vendors, customers, training activities, etc.).
  • May require PPE and periodic exposure to low dose radiation.

We support a drug free work environment EOE/M/F/Disability/Vet All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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