Design Quality Engineer (Software/Electrical) – Medical Devices

Stryker; Portage (MI); On-site; USD 101,000 - 136,000; Full time

Job summary

Stryker in Portage, Michigan is hiring a Staff Design Quality Engineer (Software/Electrical) to support our Medical business. On-site role focuses on quality during new product development and post-market support.

You will collaborate with R&D, Operations, Product Security, Testing and Regulatory; develop electrical/software development plans, lead risk management, PPAP, and design validation activities.

Qualifications

• Bachelor’s degree in software, electrical engineering, or computer science or related field.
• At least 4 years of experience in quality, manufacturing, new product development, software or engineering.

Responsibilities

• Partner with R&D to ensure product designs meet safety and effectiveness requirements.
• Validate design with customers as it matures through production launch.
• Collaborate with Product Security and R&D to align with cybersecurity practices.
• Lead risk management plans, reviews, and verify effectiveness of controls.
• Ensure supplier processes and manufacturing controls are robust.
• Participate in design reviews and track design through documentation and manufacturing.
• Lead design validation activities including usability engineering.
• Support product design and quality transfers to facilities.
• Analyze and define critical quality attributes for products and processes through risk analysis techniques.
• Contribute to final design verification and validation reports.
• Support PPAP planning and supplier communication for PPAP approval.

Skills

Quality management

Manufacturing

New product development

Software/engineering experience

Education

Bachelor's Degree in Software Engineering, Electrical Engineering, or Computer Science

Tools

FMEA

GD&T

Root Cause Analysis

Job description

Stryker in Portage, Michigan is hiring a Staff Design Quality Engineer (Software/Electrical) to support our Medical business. On-site role focuses on quality during new product development and post-market support.

You will collaborate with R&D, Operations, Product Security, Testing and Regulatory; develop electrical/software development plans, lead risk management, PPAP, and design validation activities.