Design Quality Engineer, Principal level, Contractor

Siro Diagnostics, Inc. is seeking an experienced Principal Design Quality Engineer to support a specific product development and design quality project related to our point-of-care molecular diagnostics platform.This is a project-based independent contractor role. The contractor will support design controls, risk management, design verification and validation, and related quality activities needed to advance product development and transfer readiness. The expected commitment is approximately 40 hours per week, with an anticipated hourly rate of $70 to $90 per hour, depending on experience.This role is ideal for someone with deep hands-on experience in medical device or molecular diagnostics quality systems who can quickly step into a fast-moving startup environment and help drive critical design quality deliverables.Responsibilities may include:Support and ensure compliance with design control requirements for new product developmentSupport design verification and validation activities, including review of protocols, reports, and related documentationLead or support risk management activities, including hazard analysis, DFMEA, PFMEA, fault tree analysis, risk-benefit analysis, and risk management planning and reportingServe as a subject matter expert in design controls, risk management, verification, validation, and quality system requirementsSupport transfer to production by assisting with process validation requirements, including IQ, OQ, PQ, and PPQ, using appropriate statistical tools and techniquesParticipate in the development, review, and approval of product requirements, product specifications, test protocols, reports, and design traceability matricesDevelop or review QC methods, sampling plans, procedures, statistical techniques, and test method qualificationsReview and approve verification, validation, process validation, and equipment qualification documentationSupport compliance with applicable requirements, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, and internal quality standardsInteract with suppliers on product development projects and quality issuesSupport nonconformance and CAPA activities, including investigations, root cause analysis, corrective actions, and preventive actionsLead or participate in internal and external audits, as neededMaintain current knowledge of regulatory requirements and standards applicable to molecular diagnostic test development and releaseRequirements:Bachelor's degree in a scientific or engineering field, such as Chemistry, Microbiology, Biology, Biochemistry, Engineering, or a related disciplineMinimum 8 years of relevant experience, or master's degree with 5 or more years of relevant experienceHands-on experience with design verification, design validation, and process validationStrong experience with design controls, risk management, CAPA, nonconformance systems, root cause investigations, and manufacturing process improvementExperience with quality system requirements in a regulated medical device, diagnostics, or life sciences environmentStartup experience or point-of-care molecular diagnostics experience strongly preferredExperience with process, QMS, or supplier auditing preferredLean Six Sigma, Certified Quality Engineer, or Certified Quality Auditor certification preferredExperience with SmartSolve, JAMA, Box, and Microsoft Office tools a plusStrong written and verbal communication skillsAbility to work independently, move quickly, and deliver high-quality work under tight timelinesContract Details:Role type: Independent contractorProject: Design quality, design control, risk management, and V&V support for a point-of-care molecular diagnostics development projectExpected time commitment: Approximately 40 hours per weekHourly rate: $75 to $90 per hour, depending on experienceLocation: San Diego, CA preferredDuration: Project-based, to be defined based on project needsEnvironment and Physical Requirements:This role is expected to be performed primarily in an indoor office or lab-adjacent environment. The role may require:Remaining in a stationary position for extended periodsRepeating motions such as typing or using a computerCommunicating with others to exchange informationOccasionally moving, lifting, carrying, pushing, or pulling objects up to 20 poundsAbout Siro Diagnostics:Siro Diagnostics is developing point-of-care molecular diagnostic technology. Our team is focused on building a high-quality platform that supports fast, reliable, and accessible diagnostic testing.

Created: 2026-05-09