Senior Design Quality Engineer (Software/Electrical)

Stryker; Portage (MI); On-site; USD 78,000 - 130,000; Full time

Benefits offered by this job

Medical and prescription drug benefits

Dental insurance

Vision insurance

Health Savings Account (HSA) / FSAs

401(k) plan with company match

Employee Stock Purchase Plan (ESPP)

Basic life and AD&D insurance

Short-term disability insurance

Job summary

Stryker in Portage, MI is hiring a Senior Design Quality Engineer (Software/Electrical) to support medical acute care product development with cross-functional teams. You will oversee quality activities for software and electrical design, risk management, cybersecurity, and product transfers through to manufacturing.

Responsibilities include risk planning, design reviews, verification/validation, and PPAP coordination with suppliers; a Bachelor’s in engineering and 2+ years of relevant

Qualifications

• Bachelor's degree in software, electrical or computer engineering.
• 2+ years of quality, manufacturing, or new product development experience.
• Experience with risk management and design controls is preferred.
• Knowledge of cybersecurity in medical devices is a plus.

Responsibilities

• Support quality for new product development and design transfers.
• Lead risk management plans and ensure effectiveness of controls.
• Collaborate with R&D, operations, suppliers and regulatory across the lifecycle.
• Support design verification, validation, and cybersecurity activities.
• Participate in PPAP planning and supplier qualification.

Skills

Quality engineering

Risk management

Design controls

Cybersecurity awareness

Education

Bachelor's degree in Software, Electrical or Computer Engineering

ASQ certification or master's degree in engineering

Job description

Stryker is hiring a Senior Design Quality Engineer (Software/Electrical) in Portage, MI to support our Medical Acute Care business. In this role, you will provide quality support for new product development and partner with cross-functional teams, including R&D, Operations, Manufacturing, Suppliers, Testing, Product Security, and Regulatory, throughout the development process. You will support software and electrical design quality activities, risk management, design verification and validation, cybersecurity, process controls, and product design transfer. You may also support post-market quality activities through the change control process and quality improvement projects.

What You Will Do

• Partner closely with R&D to ensure software and electrical product designs meet quality requirements for safety, effectiveness, reliability, manufacturability, cybersecurity, and usability. Support the collection of customer and market feedback to inform design requirements and validate the design as it matures through production launch.
• Lead risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, and verifying the implementation and effectiveness of design and process risk controls.
• Partner with Product Security and R&D to implement cybersecurity best practices and ensure security-related risks and requirements are addressed in the product design.
• Participate in design reviews and track how software and electrical design features, specifications, documentation, test methods, and manufacturing processes mitigate risks throughout the development process.
• Lead design validation activities, including human factors usability engineering.
• Support design verification planning and execution and contribute to the completion of final design verification and validation reports.
• Support product design and quality transfers to internal and/or external manufacturing facilities.
• Analyze and define critical quality attributes for products and processes through risk analysis techniques.
• Partner with Operations and suppliers to implement robust process controls for electrical components, assemblies, software-enabled systems, and manufacturing processes.
• Support PPAP planning by defining and communicating applicable PPAP requirements to component suppliers, and support PPAP approval.

What You Will Need

• Bachelor's degree in Software Engineering, Electrical Engineering, Computer Science Engineering, or a related engineering discipline.
• 2+ years of experience in quality, manufacturing, new product development, software, electrical engineering, or a related engineering field.

Preferred Qualifications

• Experience within the medical device or manufacturing industry.
• Familiarity with ISO 13485 (medical device quality management systems) and ISO 14971 (medical device risk management).
• Experience supporting software and/or electrical product development, design controls, verification, validation, or cybersecurity activities.
• Experience with data analysis, statistical analysis, sampling plans, statistical process control, or Minitab.
• Demonstrated applied knowledge of advanced quality tools such as FMEA, Root Cause Analysis, and Mistake Proofing/Poka-Yoke.
• Ability to read and interpret electrical schematics, technical specifications, test requirements, and engineering documentation.
• Six Sigma certification.
• ASQ certification or a master's degree in engineering.

United States of America Pay Ranges:

• USN: $77,700 - $129,500 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.