Design Quality Engineer (Hybrid)

Work Flexibility: Hybrid or Onsite

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.

What you will do

• 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. Must have the ability to advocate for product excellence and quality.

• Work cross-functionally with other departments, including R&D, Interaction Design, Regulatory Affairs, and Marketing. You will be expected to 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. To be successful in this role you must have strong interpersonal and communication skills. Must be strong in critical thinking with highly developed problem-solving skills and strong analytical skills.

What you need

Required

• Bachelors Degree

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

Preferred

• 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.

$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.

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.