Job Description

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.

Stryker is hiring a Staff Software Design Quality Engineer in San Jose, CA.

What you will do:

As part of the Endoscopy Quality team, customers and patients are at the heart of everything we do. Our Staff Software Design Quality Engineers maintain our brand of high-quality products. In this role, you will:

* Define User Needs by translating the voice of customer feedback to design user needs.
* Define 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 debug solutions of varying 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.
* Reviews design documentation and creates inspection requirements for new products via the use of an inspection requirements form attached to product drawings.
* Key reviewer of project documentation relating to design, compliance, and product testing. Final approver on product launch documentation, sending request to senior management to approve product release for sale.
* Potentially work with customers to help solve any technical issues that arise in the field.
* Act as a technical resource to troubleshoot 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:

Basic Qualifications:

* Bachelor's degree in Engineering
* Minimum 4 years experience in engineering or software related experience

Preferred Qualifications:

* Bachelors degree in Engineering (Electrical, Software, Computer Science or Biomedical with heavy focus in Software or Electrical)
* Familiarity with ISO 14971, ISO 13485, ISO 60601, ISO 62366, and/or ISO 62304
* New Product Development experience
* Familiarity with Software Development Life Cycle (IEC62304)
* Ability to evaluate code in C, C++, C, and/or .Net
* Working knowledge of embedded operating systems

Who we are:

At Stryker, quality is first in everything we do. We are driven to make healthcare better for our customers by providing innovative products and services that meet regulatory requirements through our effective quality system. We are passionately driven to produce remarkable results and seek team members who exhibit accountability, integrity, and credibility to join us in a highly engaging, fast-paced environment. We are tight-knit group who frequently enjoy team building activities in and out of office some of latest activities include pasta-making, cycling trip across the Golden Gate bridge, and a brewery tour! Come join a group comprised of talented individuals who move faster, act quicker, and are empowered to do more as a team!