Staff Design Quality Engineer (Software/Electrical)
Staff Design Quality Engineer (Software/Electrical)
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Staff Design Quality Engineer (Software/Electrical)
Stryker is hiring a Staff Design Quality Engineer (SW/EE) in Portage MI to support our Medical business. In this role you will support new product development and quality improvement projects by working closely with R&D Testing Lab Compliance Regulatory Affairs and other teams to ensure that product designs meet quality requirements such as safety and effectiveness.
Work Flexibility:Hybrid
This role requires reasonable proximity to our Stryker facility in Portage MI. You should be comfortable working 3 days a week onsite
What you will do:
- Participate in collection of initial market feedback and customer preference testing.
- Work closely with Product Security and R&D teams to accomplish product security activities and ensure the design is in line with the cybersecurity required practices.
- 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 risk controls.
- Partner with suppliers and manufacturing to implement robust process controls.
- Participate in design reviews and track how the design documentation and manufacturing process mitigate risks throughout the development process.
- Lead design validation activities including human factors engineering.
- 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.
- Contribute to the completion of final design verification and validation reports.
What you will need:
Required Qualifications:
- Bachelors Degree in Software Engineering Electrical Engineering or Computer Science Engineering (or other engineering degree with relevant electrical or software experience)
- 4 years experience in quality manufacturing new product development software or engineering.
Preferred Qualifications:
- Experience within medical device/manufacturing industry.
- Familiarity with ISO 13485 (medical device standard) and ISO 14971 (risk management standard).
- Data analysis (statistical analysis sampling plans statistical process control Minitab) experience.
- Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA) GD&T Root Cause Analysis and Mistake Proofing/Poke Yoke.
Demonstrated ability to read and interpret CAD drawings. - Six Sigma Certification.
Required Experience:
Staff IC
Employment Type
Full-Time
