Medical Device Design Assurance Engineer - Hybrid

Sitka Inc.; Flagstaff (AZ); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Stock Ownership Plan

Profit-sharing

Job summary

Gore is seeking experienced Design Assurance Engineers to join our New Product Development team in Flagstaff, AZ. You will apply design controls, risk management, and test method development to support medical device development and ensure safety and effectiveness across use environments.

This hands‑on role collaborates across functions and leadership to navigate ambiguity, manage design history file expectations, and drive product performance improvements. Travel up to 10% may be required.

Qualifications

• Experience applying design controls in medical device development.
• Proven ability to identify, assess, and mitigate risks.
• Ability to develop and validate test methods and support verification/validation.

Responsibilities

• Promote an inclusive and healthy work environment.
• Plan and execute design assurance and quality activities for new product development.
• Apply design controls to ensure user needs and performance are met.
• Develop, refine, and trace user needs, inputs, outputs, and risk controls.
• Develop and validate test methods for product/process performance.
• Plan and execute verification and validation activities for safety and effectiveness.
• Identify and mitigate product risks across development.
• Lead investigations and resolve technical uncertainties.
• Maintain DHF documentation and traceability.

Skills

Design controls

Risk management

Test method development

Statistical analysis

Cross-functional collaboration

Technical communication

Education

Bachelors in Engineering/Science

Master's degree (preferred)

Tools

Quality Management System (QMS)

Job description

Gore is seeking experienced Design Assurance Engineers to join our New Product Development team in Flagstaff, AZ. You will apply design controls, risk management, and test method development to support medical device development and ensure safety and effectiveness across use environments.

This hands‑on role collaborates across functions and leadership to navigate ambiguity, manage design history file expectations, and drive product performance improvements. Travel up to 10% may be required.