Design Quality Engineer (Hybrid)

About the position

Stryker is hiring a Design Quality Engineer with specialized focus on Software in Redmond, WA to support our Medical Business. You will work as the Design Quality partner within a cross-functional product development team to enable timely launch of the highest quality products that meets and exceeds customer and stakeholder expectations in support of a successful product lifecycle of a medical device and other Stryker product offerings. You will serve as a representative for the Quality Management System at all times and drive continuous process improvement.

Responsibilities

• Participate in the software product development process by ensuring that quality data streams are fully comprehended and that the voice of the customer and the system-of-systems needs are considered as design input.
• Advocate for product excellence and quality.
• Work cross-functionally with other departments, including R&D, Interaction Design, Regulatory Affairs, and Marketing.
• Successfully manage and complete projects in a matrix organization.
• Lead Software Risk Management activities, including characterization and estimation of risks associated with software products (IEC 62304 classification).
• Support software design failure modes and effects analysis [DFMEA] and cybersecurity risk analysis to drive appropriate controls and proper identification in downstream design outputs.
• Work with a cross-functional team to develop validation strategies for software projects that are consistent with design validation policies and procedures.
• Author or otherwise provide Quality review and approval of validation plans, protocols, reports.
• Review and approve software test plans and protocols.
• Provide input on optimization of these tasks to drive efficiency where possible.
• Identify initiatives & opportunities to enhance quality performance within the business, specifically within the software development space.
• Provide Quality input and guidance to drive the timely resolution of quality issues impacting software products, including cybersecurity.
• Participate in the CAPA process as task owner/contributor as appropriate and necessary.
• Advise on risk management investigations for HHE, PFAs, NCs and CAPAs or other post-market issues as needed.
• Facilitate ongoing collaboration with regulatory representatives and develop expertise on the regulatory requirements and software product development process for Software as a Medical Device (SaMD), non-medical device software products, and Medical Device Data Systems (MDDS).
• Manage multiple tasks and projects simultaneously and work independently.

Requirements

• Required Bachelors Degree
• 0-2 years of experience working in a highly regulated environment

Nice-to-haves

• Bachelors Degree in Engineering (biomedical engineering preferred) or Computer Science
• Basic knowledge of medical device industry policies and regulations.
• Basic knowledge of cybersecurity policies and regulations
• Prior experience working with software in a product development capacity or prior experience working in a Quality role
• Knowledge of good design practices, software architecture, requirements development, industry standards, etc.

Benefits

• $79,500.00 - $123,500.00 USD 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.