Job Description
As a Software Quality Engineer, you will lead Quality Engineering efforts for both software and hardware product development teams. You will be responsible for overseeing design control risk management and other quality engineering activities, ensuring the successful development and maintenance of new product development projects.
ResponsibilitiesProvide Quality Engineering leadership for software and hardware product development teams.Lead 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.Develop and maintain the Risk Management File, including risk management plans, hazards analysis, dFMEAs, pFMEAs, and risk management report.Review and approve the Design History File and associated documentation.Oversee product development plans, design inputs and outputs, verification and validation, and review of test planning protocols and reports.Guide statistical methods and analyses for design verification and validation, including test method validation.Serve as the Subject Matter Expert for software quality and collaborate on code reviews and software security analysis.Lead implementation of best practices for software quality processes.Participate in design reviews to ensure effective development, transfer, and maintenance of product hardware and software.Support successful transfer and hyper-care phase of design and design modifications into production/field deployment.Provide Quality Engineering support for anomalies encountered in production and development projects.Lead changes to the Quality System based on new regulations and industry standards.Resolve and timely close CAPAs related to the design control process.Support released products interfacing with customer support representatives and account executives.Essential SkillsExperience with FDA CFR 820, IEC series, and IEC standards.Design development, verification, validation, and test activities for medical device hardware and software.Deployment of quality engineering tools for design and process improvement.Exceptional verbal and written communication skills.Proven ability to manage multiple projects and prioritize work independently.Advocate for quality and regulatory compliance.Proficient in Microsoft Office, Adobe Acrobat, statistical analysis (e.g., Minitab), and other business software.8 years of progressive Quality Engineering experience in the Medical Device industry.Additional Skills & QualificationsCertified ASQ CQE and/or Six Sigma Black Belt/Green Belt preferred.Experience with artificial intelligence and working within an AAMI TIR45 framework.Experience supporting development of AI software algorithms and understanding of cloud infrastructure.B.S./M.S. in a relevant engineering field or equivalent scientific degree.Work Environment
This role offers the possibility of temp to hire and operates on a hybrid schedule. The working hours are 8am-5pm Pacific Time. Local candidates are preferred, with a requirement to come to the office regularly, approximately 3 days per week, or as needed. Remote work is possible with some travel to the site.
We reserve the right to pay above or below the posted wage based on factors unrelated to sex, race, or any other protected classification.
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. This temporary role may be eligible for the following:
· Medical, dental & vision
· 401(k)/Roth
· Insurance (Basic/Supplemental Life & AD&D)
· Short and long-term disability
· Health & Dependent Care Spending Accounts (HSA & DCFSA)
· Transportation benefits
· Employee Assistance Program
.Time Off/Leave (PTO, Vacation or Sick Leave)
Pay and BenefitsThe pay range for this position is $90.00 - $105.00/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 Aug 27, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.