Senior Design Quality Engineer (Software/Electrical) jobs in United States
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Stryker · 1 month ago

Senior Design Quality Engineer (Software/Electrical)

positionPortage, Michigan
timeFull-time
remoteHybrid
seniorityMid, Senior Level
date2+ years exp

Stryker is one of the world’s leading medical technology companies, and they are seeking a Senior Design Quality Engineer to ensure their innovative products meet the highest standards of safety and effectiveness. In this role, you will collaborate with R&D and cross-functional teams, lead risk management activities, and support product design transfers to improve patient outcomes worldwide.

BiotechnologyHealth CareLife ScienceMedicalMedical Device
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

Ensure product designs meet quality, safety, and effectiveness requirements by partnering with R&D and cross-functional teams
Lead risk management activities for new product development, including creating plans, conducting reviews, and verifying risk controls
Execute design validation activities, including human factors engineering and usability testing
Collaborate with Product Security and R&D teams to implement cybersecurity best practices in product design
Participate in design reviews and track risk mitigation throughout development and manufacturing processes
Support product design transfers to internal and external manufacturing facilities
Analyze and define critical quality attributes for products and processes using risk analysis techniques
Partner with suppliers and manufacturing to implement robust process controls and quality improvements

Qualification

Risk managementDesign validationISO 13485ISO 14971Statistical analysis toolsSix Sigma certificationSoftware DevelopmentConnectivity technologyRead CADCollaboration skills

Required

Bachelor's degree in Software Engineering, Electrical Engineering, Computer Science Engineering, Biomedical Engineering, or related field with relevant experience
2+ years of experience in quality, manufacturing, new product development, software, or engineering

Preferred

Experience in the medical device or manufacturing industry
Familiarity with ISO 13485 and ISO 14971 standards
Knowledge of statistical analysis tools (e.g., Minitab) and advanced quality tools (FMEA, GD&T, Root Cause Analysis)
Experience with Software Development and Connectivity technology such as Wi-Fi, Bluetooth, UWB (ultra wide band)
Ability to read and interpret CAD drawings
Six Sigma certification

Company

Stryker

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Stryker is a medical technology company that offers products and services in orthopaedics.
dateFounded in 1941
location
Kalamazoo, Michigan, USA
people-size10001+ employees
web-link
http://www.stryker.com/en-us/index.htm

H1B Sponsorship

Stryker has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)

Funding

Current Stage
Public Company
Total Funding
unknown
1990-01-02IPO

Leadership Team

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Kevin Lobo
Chair & CEO
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Glenn S. Boehnlein
Chief Financial Officer and Vice President
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Recent News

EIN Presswire
Neurointerventional Devices Market is Projected to Increase at a CAGR of 7.2% Through 2025-2029
2025-08-22
GlobeNewswire News Room
UAE General Surgery Devices Market Trends & Opportunities, 2020-2024 & 2025-2030 | Minimally Invasive Surgical Technologies Gain Traction, Advanced General Surgery Devices Fuels Demand
2025-07-04
GlobeNewswire News Room
Stryker announces Allan Golston will retire from Board of Directors
2025-02-11
Company data provided by crunchbase