Job Title: Senior Software Quality Engineer

Job Description

As a Senior Software Quality Engineer, you will partner with development teams and cross-functional stakeholders to provide technical and strategic feedback associated with the development of medical device software, digital health products, cloud-based systems, AI/ML algorithms, and cybersecurity. Your role will involve ensuring compliance with applicable regulations and standards while focusing on quality oversight and approval of software product development plans.

ResponsibilitiesPartner with development teams and cross-functional stakeholders to provide technical and strategic feedback for medical device software development.Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated design control documentation.Oversee software product development plans, risk management, design inputs and outputs, verification and validation, and review of test planning, protocols, and reports.Lead activities for establishing, implementing, and maintaining medical device software Risk Management Files (RMF).Establish and cultivate positive relationships with cross-functional stakeholders and product development team members.Provide guidance on statistical methods and analyses for design verification and validation.Serve as the SME for software quality, collaborate on code reviews, software security analysis, defect and vulnerability triage, and lead best practices for software quality processes.Participate in design reviews to ensure effective development, transfer, and maintenance of the product throughout the product lifecycle.Support the successful transfer and hyper-care phase of design and design modifications into production/field deployment.Support/lead non-product software assessments and qualification efforts.Lead changes to the Quality System based on new regulations, mentorship documents, industry standards, and observations.Own the resolution and timely closure of CAPAs related to the design control process.Follow documented procedures for all activities related to the Company's Quality System.Support other areas of the Quality System and perform other tasks as defined by Management.Complete other duties as assigned.Essential SkillsExperience supporting development of medical device software, digital health products, cloud-based systems, and AI/ML algorithms.Experience with establishing, implementing, and maintaining medical device software Risk Management Files.Experience with design control and Design History File documentation for medical device software.Experience with Agile development methodologies.Proficient in quality engineering tools for design and process improvement, statistical tools, and data analysis techniques.Strong understanding of US and international medical device regulations and standards.Understanding of Secure Product Development Framework (SPDF) and related security risk management.Strong verbal, written communication, and presentation skills.Excellent writing skills for developing clear and logical information.Ability to manage numerous projects and prioritize work independently.Organized self-starter with the ability to work in a fast-paced environment.Ability to work independently and as part of a team.Proficient in Microsoft Office, Azure DevOps, Adobe Acrobat, statistical analysis tools, vulnerability scanning, and other business software.Additional Skills & QualificationsSolid understanding of artificial intelligence and SaMD preferred.Certified ASQ CQE, and/or Six Sigma Black Belt/Green Belt preferred.Experience working within an AAMI TIR45 framework for the development of SaMD preferred.Experience supporting development of cloud-based software and understanding of cloud infrastructure preferred.Experience in security risk management and related standards preferred.B.S./M.S. in relevant engineering field (e.g., biomedical, computer science, software, electrical) or equivalent scientific degree.Minimum of eight (8) years of progressive Quality Engineering experience in the medical device industry with hands-on support for software development.Work Environment

Hybrid in Bellevue, WA. The role requires the ability to perform duties and responsibilities remotely or on-site. The work environment includes a collaborative atmosphere where team members work together to achieve project success.

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 Benefits

The pay range for this position is $70.00 - $75.00/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 Mar 3, 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.