Senior Quality Design Engineer - Software (HYBRID)

    • Stryker
  • San Jose, CA
  • Posted 23 days ago | Updated 2 days ago

Overview

On Site
USD 85,500.00 - 182,100.00 per year
Full Time

Skills

Human factors and ergonomics
Research and Development
Product development
C++
Medical devices
Healthcare information technology
Professional development
Work ethic
Collaboration
System requirements
Risk assessment
Test cases
Project documentation
Product QA
Customer satisfaction
Issue resolution
Concept development
Product design
Computer science
Computer engineering
Biomedical engineering
Software development
Risk management
ISO 13485
C#
Design
Research
Health care
Leadership
Recruiting
Brand
Computer hardware
Partnership
Specification
Cyber security
Data
FDA
Database
Usability
SAFE
Debugging
Workflow
Regulatory Compliance
Electrical engineering
Electromechanics
ISO 9000
C
Insurance
Finance
Sales

Job Details

Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team:

We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Stryker is hiring a Senior Design Quality Engineer - Software as part of the Endoscopy Quality team in San Jose , CA. This Design Quality Engineer will maintain our brand of high-quality products by defining User Needs by translating the voice of customer feedback to design user needs and partner with other NPD functions to bring new products (Hardware and Software) from concept to launch.

Workplace Flexibility: Candidate must reside within a commutable distance to San Jose, CA but is expected to be onsite at the facility multiple times/week.

Who we want:
  • Patient-oriented achievers. Engineers with an unparalleled work ethic and customer-focused attitude who bring value to their partnerships.
  • Charismatic networkers. Relationship-savvy people who intentionally make connections with both internal partners and external contacts.
  • Challengers & Influencers. People who constantly challenge themselves and each other to achieve more & to win the right way.
  • Teammates. Partners who listen to ideas, share thoughts and work together to move the business forward.


What you will do:
  • Define User Needs by translating the voice of customer feedback to design user needs.
  • Partner with other NPD functions to bring new products (Hardware and Software) from concept to launch.
  • Provide inputs into Software Requirement Specifications and ensure they are testable, unambiguous and cover the full functionality of the code and user needs.
  • Conduct Product and Cybersecurity Risk Assessments by working with current product quality data, FDA MAUDE database, and other sources to find issues with currently marketed products, assess clinical risk to customer and patients, and offer design recommendations to improve product safety, reliability, durability and performance.
  • Provide risk assessment for software defects and drive resolution by using a risk-based approach.
  • Provide Usability / Human Factors Engineering to Identify areas for improving intuitive use, usability of products through usability protocols, formative studies - executing studies with actual users (surgeon, nurse, technician, specialists).
  • Partner closely with R&D to build security and safety into the design code to ensure products are safe and effective for the end user.
  • Review code and support debugging issues of moderate complexity. Ensure test cases are clinically relevant and reflect the workflow of the end user.
  • Work with software engineers to ensure that all modules will integrate properly.
  • Present designs for peer review to improve the quality of a design and share best practices.
  • Support reviews of project documentation relating to design, compliance, and product testing.
  • Potentially work with customers to help solve any technical issues that arise in the field.
  • Support troubleshooting of problems and ensure that customer satisfaction is achieved through issue resolution.
  • Visits customer sites to observe OR workflow, surgical procedures, and products in use as required to support concept development or issue resolution.


What you will need:

Required:
  • Bachelor's degree in engineering
  • 3+ years of demonstrated proficiency with product design quality or Research & Development (R&D) with some software exposure in a highly regulated environment.

Preferred:
  • Bachelor's degree in Computer Science, Software, Computer Engineering, Electrical or Biomedical Engineering with emphasis with software in medical device industry preferred.
  • Medical Device New Product Development experience
  • Experience with software heavy electromechanical devices
  • Familiarity with Software Development Life Cycle Development (IEC 62304), Usability Engineering (IEC 62366), Risk Management (ISO 14971), ISO 13485
  • Familiarity or has the ability to interpret software codes such as C, C++, C#, etc.


85,500.00 to 182,100.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
About Stryker

Our benefits:

  • 12 paid holidays annually
  • 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.

For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits

About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company 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 130 million patients annually. More information is available at stryker.com.

Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program on our referral page

Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.