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 development
- Support design verification and validation activities, including review of protocols, reports, and related documentation
- Lead or support risk management activities, including hazard analysis, DFMEA, PFMEA, fault tree analysis, risk-benefit analysis, and risk management planning and reporting
- Serve as a subject matter expert in design controls, risk management, verification, validation, and quality system requirements
- Support transfer to production by assisting with process validation requirements, including IQ, OQ, PQ, and PPQ, using appropriate statistical tools and techniques
- Participate in the development, review, and approval of product requirements, product specifications, test protocols, reports, and design traceability matrices
- Develop or review QC methods, sampling plans, procedures, statistical techniques, and test method qualifications
- Review and approve verification, validation, process validation, and equipment qualification documentation
- Support compliance with applicable requirements, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, and internal quality standards
- Interact with suppliers on product development projects and quality issues
- Support nonconformance and CAPA activities, including investigations, root cause analysis, corrective actions, and preventive actions
- Lead or participate in internal and external audits, as needed
- Maintain current knowledge of regulatory requirements and standards applicable to molecular diagnostic test development and release
Requirements:
- Bachelor’s degree in a scientific or engineering field, such as Chemistry, Microbiology, Biology, Biochemistry, Engineering, or a related discipline
- Minimum 8 years of relevant experience, or master’s degree with 5 or more years of relevant experience
- Hands-on experience with design verification, design validation, and process validation
- Strong experience with design controls, risk management, CAPA, nonconformance systems, root cause investigations, and manufacturing process improvement
- Experience with quality system requirements in a regulated medical device, diagnostics, or life sciences environment
- Startup experience or point-of-care molecular diagnostics experience strongly preferred
- Experience with process, QMS, or supplier auditing preferred
- Lean Six Sigma, Certified Quality Engineer, or Certified Quality Auditor certification preferred
- Experience with SmartSolve, JAMA, Box, and Microsoft Office tools a plus
- Strong written and verbal communication skills
- Ability to work independently, move quickly, and deliver high-quality work under tight timelines
Contract Details:
- Role type: Independent contractor
- Project: Design quality, design control, risk management, and V&V support for a point-of-care molecular diagnostics development project
- Expected time commitment: Approximately 40 hours per week
- Hourly rate: $75 to $90 per hour, depending on experience
- Location: San Diego, CA preferred
- Duration: Project-based, to be defined based on project needs
Environment 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 periods
- Repeating motions such as typing or using a computer
- Communicating with others to exchange information
- Occasionally moving, lifting, carrying, pushing, or pulling objects up to 20 pounds
About 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.