Medical Device Product Development Engineer - Hybrid Role

Sitka Inc.; Flagstaff (AZ); Hybrid; USD 100,000 - 140,000; Full time

Job summary

Sitka Inc. in Flagstaff, AZ invites applications for an experienced Product Development Engineer to join our New Product Development team focused on medical devices.

You will define requirements, support risk management, and develop test methods across cross-functional teams to ensure design controls are met. This hands-on role requires 3–5+ years of experience (senior 5+), strong analytical skills, and the ability to work independently within a regulated quality environment.

Qualifications

• Bachelor's degree in engineering/science/technical field with 3+ years of applied experience, or Master’s with 2+ years
• Senior: Bachelor's with 5+ years or Master’s with 4+ years in applied experience
• Experience identifying, evaluating, and mitigating product or process risks using structured risk management
• Experience working within a regulated quality system (QMS), exposure to design controls, investigations, or CAPA
• Experience developing, executing, or improving test methods for product/process performance
• Ability to interpret and apply requirements with traceability from user needs to tests (bidirectional traceability)
• Ability to analyze technical data and apply statistical methods
• Understanding of sampling plans and data-based decisions in regulated environments
• Ability to solve technical problems and work with cross-functional teams to completion
• Strong written and verbal communication; travel up to 10%

Responsibilities

• Promote an inclusive and healthy environment aligned with Gore culture
• Plan and execute design assurance / product quality engineering work to support new product development
• Apply design control processes to ensure products meet user needs and performance
• Develop and refine user needs, design inputs/outputs, ensuring traceability
• Develop, improve, and validate test methods for product/process performance
• Plan and execute design verification and design validation for safety and effectiveness
• Identify, evaluate, and mitigate product risks using design and usability risk management (dFMEA, uFMEA)
• Lead technical investigations to address issues and improve product performance
• Ensure DHF documentation and traceability across needs, inputs, outputs, risk controls, and verifications
• Document and communicate technical plans and results per quality system and regulatory requirements

Skills

Risk management

Design controls

Quality systems (QMS)

Data analysis

Statistical methods

Traceability

Problem solving

Independent work

Cross-functional collaboration

Communication skills

Travel readiness

Education

Bachelor’s Degree in Engineering, Science or Technical Field

Master’s Degree in Engineering, Science or Technical Field

Job description

Sitka Inc. in Flagstaff, AZ invites applications for an experienced Product Development Engineer to join our New Product Development team focused on medical devices.

You will define requirements, support risk management, and develop test methods across cross-functional teams to ensure design controls are met. This hands-on role requires 3–5+ years of experience (senior 5+), strong analytical skills, and the ability to work independently within a regulated quality environment.