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Medical Device Design Control Quality Jobs (NOW HIRING)

Future Ventures

Software Design Quality Engineer

Austin, TX · On-site

$125 - $150/hr

Own software design control impact assessments for design changes within the medical device design ... Debug software quality and design control gaps using requirements management tools, traceability ...

avalign

Sr. Design Quality Engineer

Fort Wayne, IN · On-site

Responsible for supporting a design control quality system that is complaint to ISO 13485 (latest revision), the Medical Device Directives (while active), and the EU Medical Device Regulations (MDR)

ICU Medical

Engineer III, Product Design

Southington, CT · On-site

$131K - $157K/yr

... quality, regulatory, and medical groups-to ensure that all product designs meet regulatory ... As a subject matter expert (SME) in medical device development, this position will drive key ...

Merck & Co.

$142K - $224K/yr

... medical device and combination product operations which require above-site support:Accountable for ... Familiarity with device design verification and design control aspectsStrong knowledge of device ...

Biogen

Senior Device Quality Engineering Lead

Cambridge, MA · On-site

$138K - $185K/yr

As the Senior Device Quality Engineering Lead, you will hold a pivotal role in ensuring the quality oversight of design control and risk management activities for combination products and medical ...

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Medical Device Design Control Quality information

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$36K

$81K

$126.5K

How much do medical device design control quality jobs pay per year?

As of Sep 8, 2026, the average yearly pay for medical device design control quality in the United States is $81,001.00, according to ZipRecruiter salary data. Most workers in this role earn between $60,000.00 and $97,000.00 per year, depending on experience, location, and employer.

What are medical device design control quality requirements?

Medical device design control quality requirements are regulatory standards that ensure the safety, effectiveness, and performance of medical devices throughout their development lifecycle. These requirements, defined by agencies like the FDA, mandate a systematic process that includes design planning, input and output documentation, verification, validation, and risk management. Adhering to design controls helps manufacturers identify and address potential issues early, ensuring the final product meets both user needs and regulatory expectations. Compliance with these requirements is critical to obtaining market approval and maintaining product quality.

What are some common challenges faced by professionals in medical device design control quality, and how can they be effectively addressed?

Professionals in Medical Device Design Control Quality often face challenges such as ensuring compliance with complex and evolving regulatory standards (like FDA 21 CFR 820 and ISO 13485), managing thorough documentation throughout the product lifecycle, and facilitating effective cross-functional communication between engineering, regulatory, and manufacturing teams. These challenges can be addressed by staying updated on regulatory changes, implementing robust document control systems, and fostering a collaborative environment where regular meetings and clear communication channels are established. Continuous training and leveraging quality management software can also help streamline processes and maintain compliance.

What are the key skills and qualifications needed to thrive as a medical device design control quality professional, and why are they important?

To excel in Medical Device Design Control Quality, you need a solid background in engineering or life sciences, knowledge of FDA and ISO 13485 regulations, and experience with design control processes. Familiarity with quality management systems (QMS), risk management tools like FMEA, and document control software is typically required. Strong attention to detail, problem-solving abilities, and effective communication skills help ensure compliance and facilitate cross-functional collaboration. These competencies are essential for ensuring product safety, regulatory approval, and the successful launch of medical devices.

What is the difference between Medical Device Design Control Quality vs Medical Device Quality Assurance?

AspectMedical Device Design Control QualityMedical Device Quality Assurance
FocusEnsuring design processes meet regulatory standards and are properly documentedVerifying overall product quality and compliance through testing and inspections
ResponsibilitiesManaging design controls, risk management, and design verification/validationImplementing quality systems, audits, and corrective actions
CredentialsBackground in engineering, quality systems, and regulatory knowledgeExperience in quality management, auditing, and compliance

While both roles aim to ensure medical device safety and compliance, Medical Device Design Control Quality focuses on managing the design process and documentation, whereas Medical Device Quality Assurance emphasizes overall product quality and compliance through testing and audits.

What are popular job titles related to Medical Device Design Control Quality jobs?

For Medical Device Design Control Quality jobs, the most frequently searched job titles are:

Infographic showing various Medical Device Design Control Quality job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 90% Physical, 1% Hybrid, and 9% Remote job distribution, with an average salary of $81,001 per year, or $38.9 per hour.

Medical Device Design Quality Engineer

Pittsburgh, PA • On-site

Experis
Recruiting and Staffing Services • 10K+ employees
Learn more about Experisexternal

$37 - $42/hr

Other

Medical, Dental, Vision, Life, Retirement

Posted 11 days ago

Job description

Our client, a leading organization in the medical device industry, is seeking a Medical Device Design Quality Engineer to join their team. As a Medical Device Design Quality Engineer, you will be part of the Quality Assurance department supporting product development and manufacturing teams. The ideal candidate will demonstrate strong analytical skills, attention to detail, and a proactive mindset, which will align successfully in the organization.

Job Title: Medical Device Design Quality Engineer

Location: Pittsburgh, PA (Onsite)

Pay Range: $37-$42/Hr. on W2

What's the Job?

  • Support design quality activities throughout new product development, including design reviews, requirements review, risk management, verification and validation planning, and design transfer readiness.
  • Lead and participate in Design Failure Modes and Effects Analysis (DFMEA) and risk assessments to identify and mitigate design and manufacturing risks.
  • Review protocols and participate in V&V planning to ensure alignment with product requirements and risk controls.
  • Support design transfer activities by ensuring product and process requirements are translated into manufacturing, inspection, supplier, validation, and release deliverables.
  • Manage and drive timely resolution of nonconformances (NCs) and corrective & preventive actions (CAPAs).

What's Needed?

  • Bachelor's degree in Engineering, Quality, or a related field (Master's preferred).
  • 3+ years of experience in medical device quality engineering or a related field.
  • Strong knowledge of ISO 13485, FDA QSR (21 CFR Part 820), EU MDR, and risk management (ISO 14971).
  • Experience with Design Control, Process Validation, CAPA, and Supplier Quality.
  • Proficiency in statistical analysis tools (Minitab) and problem-solving methodologies (8D, DMAIC).

What's in it for me?

  • Opportunity to work in a dynamic and innovative environment.
  • Immediate start with potential for long-term career growth.
  • Collaborate with a dedicated team of professionals in the medical device industry.
  • Engage in meaningful work that impacts patient safety and healthcare advancements.
  • Supportive work culture emphasizing continuous improvement and professional development.

Upon completion of waiting period consultants are eligible for:

  • Medical and Prescription Drug Plans
  • Dental Plan
  • Vision Plan
  • Health Savings Account
  • Health Flexible Spending Account
  • Dependent Care Flexible Spending Account
  • Supplemental Life Insurance
  • Short Term and Long Term Disability Insurance
  • Business Travel Insurance
  • 401(k), Plus Match
  • Weekly Pay

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis and Talent Solutions.

Experis® is a global leader in technology services and part of the ManpowerGroup® (NYSE: MAN) family of brands. We connect skilled technology professionals with meaningful opportunities where they can grow their careers, expand their expertise and make a real impact. Guided by the belief that it takes Human Ingenuity to unlock the true potential of technology, Experis helps people gain experience with leading organizations, build sought-after skills and take the next step toward a brighter future. Backed by ManpowerGroup's 75+ years of workforce expertise and global reach across more than 70 countries and territories, Experis brings the scale, insight and opportunity to help people and businesses thrive. ManpowerGroup is consistently recognized for its commitment to inclusion, ethics and responsible business, including being named one of the World's Most Ethical Companies. Learn more at Experis.com.

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