Stanford, California
SUMMARY OF ROLE
Inflammatix is seeking a Design Assurance Engineer to fulfill the design assurance role on new product development (concept to launch) projects and contribute to sustaining engineering for on market products. The ideal candidate will thrive in a fast-paced start up environment and will work with high performance cross-functional teams to plan and execute Design Controls, Risk Management, Test Method Development and Validation, Design Verification and Validation for new and existing products. This position reports directly to the Vice President of Program Management and Design Assurance and works closely with the Principal Design Assurance Engineer.
PRIMARY RESPONSIBILITIES:
• Create and maintain project risk management documentation (Hazard Analysis, DFMEA, PFMEA, UFMEA)
• Generate test protocols, manage test execution, investigate test issues, analyze data, and create reports for design verification and validation testing.
• Support the development and validation of new test methods.
• Partner with Technical Team to determine and define design inputs, design outputs, and design trace matrices
• Partner with Manufacturing Team to develop specifications and acceptance tests
• Support design transfer of new product development projects from development to operations.
• Provide direction to design assurance technicians or interns supporting assigned projects.
• Support improvement of Design Assurance specific quality system deliverables and processes to increase effectivity and efficiency.
• Contribute to design and process change initiatives on commercialized product.
• Support internal and external audits.
QUALIFICATIONS, SKILLS, AND ABILITIES:
• Minimum of five (5) years medical device or in vitro diagnostics experience
• S. degree (scientific or engineering)
• Basic knowledge of ISO 13485, ISO 14971 and Quality System Regulations
• Excellent communication, interpersonal and negotiation skills
• Time management skills
• Proficiency in technical report writing
• Ability to work on a team and as an individual contributor.
• Skilled at a structured and methodical problem-solving approach.
• Understanding of statistics and ability to use statistical analysis software
COMPENSATION AND CLASSIFICATION:
• Location: San Francisco Bay Area (headquarters is in Burlingame)
• Classification: Full-time
• Compensation: Competitive and commensurate with experience; includes equity package
• Benefits: Medical, dental, and vision; 401(k), generous leave and more
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