Software Quality Engineer

Sr. Principal Software Quality Engineer

Pay Rate: $85/hr

Hours: 8am-5pm Pacific Time

Work Environment: Hybrid - Local candidate preferred. Will be working with engineers and will need to come to the office on a regular basis - 3 days per week or as needed. Open to remote with some travel to site.

Required:

8 years of progressive Quality Engineering experience in the Medical Device industry with hands-on support for hardware and software development.

Main Duties and Responsibilities:

- Provide Quality Engineering leadership for software and hardware product development teams. Responsible for leading design control risk management and other Quality Engineering activities for new product development projects.

- Establish and nurture strong relationships with cross-functional product development team members to optimize success of development projects.

- Lead the development and maintenance of the Risk Management File RMF including risk management plans hazards analysis dFMEAs pFMEAs and risk management report.

- Provide Quality Engineering input review and approval of the Design History File DHF and associated documentation. Responsible for quality oversight and approval of product development plans design inputs and outputs verification and validation and review of test planning protocols and reports.

- Provide guidance on statistical methods and analyses for design verification and validation including test method validation.

- Serve as the SME for software quality and collaborate with teams on code reviews software security analysis and the software BOM lead implementation of best practices for software quality processes.

- Participate in design reviews to ensure the effective development transfer and maintenance of the product hardware and software throughout the product lifecycle.

- Support the successful transfer and hyper-care phase of design and design modifications into production / field deployment.

- Provide Quality Engineering support for anomalies e.g. software bugs cybersecurity vulnerabilities etc. encountered in production and development projects. Guide triage and remediation efforts.

Secondary/Backup Duties and Responsibilities:

- Lead changes to the Quality System based on new regulations guidance documents industry standards and observations.

- Own the resolution and timely closure of CAPAs as they relate to the design control process.

- Provide Quality Engineering support for released products interfacing with customer support representatives and account executives as necessary.

- Support other areas of the Quality System and perform other tasks as defined by Management

Skills: software validation, quality engineering

Top Skills Details: software validation, quality engineering

Additional Skills & Qualifications:

- Experience with the application and implementation of FDA CFR 820 ISO 13485 ISO 14971 IEC 60601 series IEC 62304 and IEC 62366.

- Experience in the design development verification validation and test activities for medical device hardware and software including electromechanical medical devices and both embedded and non- embedded software.

- Experience in the deployment of quality engineering tools for design and process improvement extensive knowledge of statistical tools and data analysis techniques.

- Exceptional verbal and written communication skills and presentation skills.

- Exceptional attention to detail with the proven ability to wear many hats.

- Manage multiple projects while independently prioritizing work growing the quality culture and being an advocate for quality and regulatory compliance.

- Must be comfortable working in a high-growth company with rapidly evolving needs responsibilities and expectations.

- Creative problem solver.

- Proficient in Microsoft Office Adobe Acrobat statistical analysis e.g. Minitab and other business software.

Additional Qualifications:

- Certified ASQ CQE and/or Six Sigma Black Belt/Green Belt preferred.

- Experience with artificial intelligence working within an AAMI TIR45 framework and SaMD is preferred.

- Experience supporting development of classic and artificial intelligence AI software algorithms and deep understanding of cloud infrastructure is preferred.

Education and Experience:

8 years of progressive Quality Engineering experience in the medical device industry with hands-on support for hardware and software development.

B.S./M.S. in relevant engineering field e.g. biomedical software electrical etc. or equivalent scientific degree.

Physical Demands and Work Environment:

Ability to work with computers in a hybrid / office environment and complete occasional physical tasks normal to that environment.

Experience Level: Intermediate Level

Pay and Benefits:

The pay range for this position is $85.00 - $85.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type: This is a hybrid position in Bellevue, WA.

Application Deadline: This position is anticipated to close on Oct 28, 2025.