Title: Sr. Principal Software Quality Engineer
Duration: 12 Months (temp to hire)
Location: Bellevue, WA (Hybrid)

Hybrid – candidate will be working with engineers and will need to come to the office on a regular basis

Job Description
Essential Duties and Responsibilities

• Partner with development teams and cross-functional stakeholders to provide technical and strategic feedback associated with the development of medical device software (SaMD and SiMD), digital health products, cloud-based systems, AI/ML algorithms and cybersecurity aligned with applicable regulations, standards, and business needs.
• Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated design control documentation for medical device software. Responsible for quality oversight and approval of 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), including analyzing and evaluating risks, controlling identified risks, and monitoring the effectiveness of the risk control measures.
• Establish and cultivate positive relationships with cross-functional stakeholders and product development team members to optimize the success of development projects.
• 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, defect and vulnerability triage, creation and maintenance of sBOMs, etc., and lead implementation of best practices for software quality processes.
• Participate in design reviews to ensure the 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 as they relate 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.

Qualifications

• Experience supporting development of medical device software (SaMD and SiMD), digital health products, cloud-based systems, and AI/ML algorithms.
• Experience leading activities for establishing, implementing, and maintaining medical device software Risk Management Files.
• Experience supporting the development of design control and design history file documentation for medical device software from inception through successful Design Transfer.
• Experience supporting software development teams using Agile development methodologies including supporting iteration planning, execution, demonstrations, and retrospective activities.
• Experience in the deployment of quality engineering tools for design and process improvement; extensive knowledge of statistical tools and data analysis techniques.
• Strong solid understanding of US and international medical device regulations and standards, including 21 CFR 820, ISO 13485, IEC 62304, IEC 82304, AAMI TIR45, ISO 14971, AAMI TIR57, IEC 60601 series, IEC 62366.
• Solid understanding of Secure Product Development Framework (SPDF), including security risk management per AAMI TIR57, creation and maintenance of sBOMs, security architecture, security testing, transparency, and post-market vulnerability management.
• Strong verbal and written communication and presentation skills. Demonstrated interpersonal skills including strong negotiation skills.
• Excellent writing skills to develop clear and logical information and conclusions based on design documentation.
• Ability to manage numerous projects while independently prioritizing work, growing the quality culture, and being an advocate for quality and regulatory compliance.
• Organized self-starter, able to work in a fast-paced environment.
• Ability to work independently and as part of team, strong collaborative skills.
• Ability to manage competing priorities and “wear many hats.”
• Must be comfortable working in a high-growth company with rapidly evolving needs, responsibilities, and expectations.
• Proficient in Microsoft Office, Azure DevOps, Adobe Acrobat, statistical analysis (e.g., Minitab), vulnerability scanning, and other business software.
• Ability to perform duties and responsibilities remotely or on-site.
• Solid 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 deep understanding of cloud infrastructure preferred.
• Experience in security risk management and ISO/IEC 27001 preferred.

Education and Experience

• B.S./M.S. in relevant engineering field (e.g., biomedical, computer science, software, electrical, etc.) or equivalent scientific degree.
• Minimum of eight (8) plus years of progressive Quality Engineering experience in the medical device industry with hands-on support for software development

 

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
 
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
 
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer. 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $16.66/hr.