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Quality Engineer Medical Device Jobs (NOW HIRING)

Mizuho OSI

Systems Engineer, Medical Device

Union City, CA · On-site

$82K - $150K/yr

... Systems Engineer you will be part of a small, agile team; responsible for medical device ... Understand, follow and support Mizuho OSI's internal Quality System policies, procedures and work ...

Mizuho OSI

Systems Engineer, Medical Device

Union City, CA · On-site

$82K - $150K/yr

... Systems Engineer you will be part of a small, agile team; responsible for medical device ... Understand, follow and support Mizuho OSI's internal Quality System policies, procedures and work ...

Actalent

Medical Device Engineer

Aurora, CO · Hybrid

$57.69/hr

Partner with Quality, Regulatory Affairs, Manufacturing, and R&D teams throughout the product ... engineering discipline. * Experience supporting medical device development or work within a highly ...

Mitovation

Be Seen First

Systems Engineer - Medical Device Company

Ann Arbor, MI · On-site

$110K - $140K/yr

... and Class II medical device design controls. * Help stand up engineering processes and ... Support buildout of a Quality Management System (QMS) in anticipation of future ISO 13485 ...

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All JobsQuality Engineer Medical Device Jobs

Quality Engineer Medical Device information

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How much do quality engineer medical device jobs pay per hour?

As of Aug 11, 2026, the average hourly pay for quality engineer medical device in the United States is $36.72, according to ZipRecruiter salary data. Most workers in this role earn between $24.76 and $45.91 per hour, depending on experience, location, and employer.

What does a quality engineer do in the medical device industry?

A Quality Engineer in the medical device industry is responsible for ensuring that medical devices meet all regulatory standards and quality requirements. They develop and implement quality assurance processes, perform risk assessments, and conduct inspections and audits to make sure products are safe and effective. Quality Engineers also collaborate with design, manufacturing, and regulatory teams to resolve quality issues and improve product reliability. Their work is crucial for maintaining compliance with standards such as ISO 13485 and FDA regulations.

What is the difference between Quality Engineer Medical Device vs Quality Assurance Specialist Medical Device?

AspectQuality Engineer Medical DeviceQuality Assurance Specialist Medical Device
CertificationsISO 13485, Six Sigma, ASQ certificationsISO 13485, Six Sigma, ASQ certifications
Work EnvironmentDesign, development, manufacturing, and process improvementAuditing, compliance, documentation, and process verification
Employer & Industry UsageMedical device manufacturers, R&D labsMedical device companies, regulatory agencies, consulting firms

While both roles focus on quality in the medical device industry, a Quality Engineer Medical Device primarily works on product design, process development, and continuous improvement. In contrast, a Quality Assurance Specialist Medical Device emphasizes compliance, auditing, and ensuring adherence to regulatory standards. Both roles are essential for maintaining product safety and quality, but they differ in scope and daily responsibilities.

What are the key skills and qualifications needed to thrive as a quality engineer in the medical device industry?

To thrive as a Quality Engineer in the medical device industry, you need a strong background in quality assurance, regulatory compliance (such as ISO 13485 and FDA 21 CFR Part 820), and engineering principles, often supported by a relevant engineering degree. Familiarity with quality management systems (QMS), risk analysis tools (like FMEA), and certifications such as CQE (Certified Quality Engineer) are typically required. Attention to detail, problem-solving, and effective communication are critical soft skills for collaborating with cross-functional teams and ensuring product safety. These skills and qualifications are vital to maintain regulatory compliance, uphold product quality, and protect patient safety in a highly regulated environment.

How does a quality engineer in the medical device industry typically collaborate with cross-functional teams to ensure product compliance?

Quality Engineers in the medical device sector work closely with cross-functional teams such as design, manufacturing, regulatory affairs, and supply chain. They participate in design reviews, risk assessments, and process validations to ensure that products meet both internal quality standards and external regulatory requirements (such as FDA or ISO 13485). Regular collaboration involves reviewing documentation, addressing non-conformances, and implementing corrective actions. This teamwork is critical to proactively identify potential issues and maintain continuous product quality throughout the development and production lifecycle.
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Quality Engineer Medical Device jobs near you
Infographic showing various Quality Engineer Medical Device job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $76,384 per year, or $36.7 per hour.

X-Ray Engineer (Medical Device)

Ziehm-OrthoScan

Scottsdale, AZ • On-site

Other

Medical, Dental, Vision, Retirement, PTO

Re-posted 4 days ago

Job description

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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