Sr Design Quality Engineer – Medical Devices

Cardinal Health; Mansfield (MA); On-site; USD 68,500 - 97,800; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Short- and long-term disability coverage

Paid parental leave

Healthy lifestyle programs

Job summary

A leading healthcare firm is looking for a Design Quality Engineer to ensure quality excellence in the development life cycle of medical devices. This role involves collaborating with cross-functional teams for design control processes, managing risk documentation, and resolving quality issues. Candidates should have a Bachelor's degree in engineering, 2+ years of experience, and a good understanding of medical device standards and regulations. Competitive salary offered based on experience and location.

Qualifications

• 2+ years of experience preferred in quality engineering or related field.
• Knowledge of medical device design and development processes.
• Understanding of AAMI, ANSI standards, GMP, ISO standards.

Responsibilities

• Create and review medical device design and development files.
• Develop risk management files throughout product lifecycle.
• Identify and resolve design-related quality issues in collaboration with teams.
• Lead continuous improvement activities and projects.

Skills

Attention to detail

Organizational skills

Problem-solving skills

Technical writing

Confident communication

Collaboration skills

Education

Bachelor’s degree in engineering or related field

ASQ CQE Certification

Tools

Statistical analysis tools

Root cause analysis

Job description

Job Summary

Design Quality Engineering drives quality excellence throughout the design and development life cycle of medical devices. This function ensures robust design control processes including risk management, design planning, design verification, design validation, and preparation for design transfer.

Design Quality Engineering collaborates with cross‑functional teams contributing to the resolution of quality issues, development and adherence to quality policies, procedures, and processes to ensure compliance with regulatory standards, and achievement of long‑term quality strategies.

Responsibilities

• Participate in the creation, review and approval of medical device design and development files including design planning, design inputs & outputs, design verification & validation, and design transfer plans.
• Develop and maintain risk management files throughout the product lifecycle, across a broad set of technologies with clear and thorough identification of hazards, hazardous situations, risk estimation and analysis, and mitigation activities to ensure continued acceptability of products.
• Work closely with Research and Development, Regulatory, Medical Affairs and Quality Operations teams to ensure timely identification, documentation, and resolution of design‑related quality issues.
• Work on projects of moderate scope and complexity, identify opportunities for continuous improvement, and lead activities to implement improvements with general guidance.
• Support all company initiatives identified by leadership and be accountable for on‑time completion of training, tasks, projects, and quality plans.

Qualifications

• Bachelor’s degree in engineering or related field preferred
• Preferred Certifications: ASQ CQE
• 2+ years of experience preferred
• Knowledge of medical device design and development, risk management processes, statistical analysis tools, root cause analysis, and continuous improvement.
• Understanding of industry standards, guidelines, and regulations (i.e. AAMI & ANSI standards, GMP, 21CFR820, ISO14971, IEC62366, ISO 13485)
• Strong attention to detail, organizational, problem‑solving, and technical writing skills.
• Confident communicator and ability to collaborate cross‑functionally
• Travel Expectations: 10%

Anticipated salary range: $68,500 - $97,800

Bonus eligible: No

Benefits

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short‑ and long‑term disability coverage
• Work‑Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 4/6/26. If interested in opportunity, please submit application as soon as possible.

Candidates who are back‑to‑work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.