Medical Device Quality Engineer — NPD & Design Assurance

Sitka Inc.; Phoenix (AZ); Hybrid; USD 95,000 - 130,000; Full time

Job summary

Gore in Phoenix, AZ seeks experienced Design Assurance Engineers/Product Quality Engineers for New Product Development. Hybrid role, hands-on design control, risk management, and cross‑functional collaboration to ensure safe, effective medical devices.

Role requires 3+ years for experienced or 5+ years for senior level, with a Bachelor’s in Engineering/Science and strong documentation skills. Travel up to 10% may be required.

Qualifications

• Bachelor’s Degree in Engineering, Science or Technical Field with solid knowledge and 3+ years of applied experience (Experienced).
• Bachelor’s Degree with 5+ years of applied experience or Master’s with 2+ years for Experienced track.
• Senior position requires 5+ years (Bachelor’s) or 4 years with Master’s.
• Experience identifying, evaluating, and mitigating product/process risks.

Responsibilities

• Plan and execute design assurance / product quality work for new product development.
• Apply design control processes to ensure user needs and performance.
• Develop and refine user needs, design inputs/outputs, and traceability.
• Develop, validate and refine test methods for product performance.
• Plan and execute design verification and validation activities.
• Identify and mitigate risks across development; apply bidirectional traceability.
• Lead investigations to resolve technical issues and improve product performance.
• Maintain DHF documentation and linkage across needs, inputs, outputs, and risks.
• Document plans, results and conclusions per quality system requirements.

Skills

Risk management

Design controls

Cross-functional collaboration

Independent work

Communication

Education

Bachelor’s Degree in Engineering/Science/Technical Field

Master’s degree (optional)

Job description

Gore in Phoenix, AZ seeks experienced Design Assurance Engineers/Product Quality Engineers for New Product Development. Hybrid role, hands-on design control, risk management, and cross‑functional collaboration to ensure safe, effective medical devices.

Role requires 3+ years for experienced or 5+ years for senior level, with a Bachelor’s in Engineering/Science and strong documentation skills. Travel up to 10% may be required.