Senior Design Quality Engineer SoftwareElectrical
Senior Design Quality Engineer SoftwareElectrical
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1 Vacancy
Job Description
Senior Design Quality Engineer (Software/Electrical)
Stryker is one of the worlds leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies including reconstructive medical and surgical and neurotechnology and spine products to help people lead more active and more satisfying lives.
We are currently seeking a Senior Design Quality Engineer (SW/EE) in Portage MI to support design assurance activities for products in development.
Work Flexibility:Hybrid
This role requires reasonable proximity to our Stryker facility. You should be comfortable working 3 days a week onsite
What you will do:
- Support product quality sustainment through targeted exposure to postmarket quality function and change controls process. Partner with R&D and execute quality improvement projects.
- Work closely with the R&D team to ensure that product designs meet quality requirements such as safety and effectiveness; participate in collection of initial market feedback and customer preference testing.
- Work closely to 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.
- Complete 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)
- 3 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.
- MS in engineering.
- Demonstrated ability to work crossfunctionally with other departments including Advanced Operations Research and Development Regulatory Affairs Clinical Sciences and Marketing.
Required Experience:
Senior IC
Employment Type
Full-Time
