Shifamed · 8 hours ago
Sr. Quality Engineer
Los Gatos, CA
Full-time
Onsite
Senior Level
$130K/yr - $160K/yr
6+ years expShifamed is a medical device innovation hub focused on developing novel medical products in cardiology and ophthalmology. They are seeking a Senior Quality Engineer to drive quality and compliance in design and development, influencing early-stage designs and ensuring adherence to quality management systems.
Health CareMedical Device
Responsibilities
Drive design controls deliverables, including but not limited to DHF, design phase reviews, specification tracing to design outputs, design verification documentation and risk management documentation
Develop risk management files and associated deliverables, such as FMEA and hazard analysis
Develop QMS infrastructure and processes per FDA Quality System Regulations and ISO 13485 and ensure the compliance to these processes
Prepare technical documentation to support design control activities and regulatory submissions including technical design change analysis, V&V plans and reports, manufacturing instructions, test methods, protocols, and reports
Provide guidance on applicable standards and regulations and enable implementation of those into designs
Develop quality inspection methods and processes in manufacturing and design
Qualify and maintain the suppliers per the supplier management process
Provide periodic updates regarding project status
Proven experience of Design Controls and Risk Management for electromechanical medical device and/or interventional cardiology products
Strong proficiency and exposure to strong Design Verification and Design Validation, including statistical techniques and data analysis
Expertise in one or more areas is highly preferred: human factors and usability engineering, clinical studies, biocompatibility and sterilization validation, software development life cycle (62304), product labeling, and electronics testing (60601) and reliability
Demonstrated ability of working with suppliers, including understanding of capabilities, materials, and fabrication processes is desired
Working and demonstrated knowledgeable about medical device regulations, including FDA QSR, 13485, EU MDR etc
Excellent communication skills: ability to work both independently and in project team setting
Ability to travel
Qualification
Required
Drive design controls deliverables, including but not limited to DHF, design phase reviews, specification tracing to design outputs, design verification documentation and risk management documentation
Develop risk management files and associated deliverables, such as FMEA and hazard analysis
Develop QMS infrastructure and processes per FDA Quality System Regulations and ISO 13485 and ensure the compliance to these processes
Prepare technical documentation to support design control activities and regulatory submissions including technical design change analysis, V&V plans and reports, manufacturing instructions, test methods, protocols, and reports
Provide guidance on applicable standards and regulations and enable implementation of those into designs
Develop quality inspection methods and processes in manufacturing and design
Qualify and maintain the suppliers per the supplier management process
Provide periodic updates regarding project status
Proven experience of Design Controls and Risk Management for electromechanical medical device and/or interventional cardiology products
Strong proficiency and exposure to strong Design Verification and Design Validation, including statistical techniques and data analysis
Demonstrated ability of working with suppliers, including understanding of capabilities, materials, and fabrication processes is desired
Working and demonstrated knowledgeable about medical device regulations, including FDA QSR, 13485, EU MDR etc
Excellent communication skills: ability to work both independently and in project team setting
Ability to travel
B.S. or higher in Biomedical, Electrical, Mechanical or Systems Engineering or equivalent relevant work experience
6+ years of experience in a quality engineering role
Preferred
Expertise in one or more areas is highly preferred: human factors and usability engineering, clinical studies, biocompatibility and sterilization validation, software development life cycle (62304), product labeling, and electronics testing (60601) and reliability
Experience in the medical device industry with electromechanical products and/or interventional cardiology products is preferred
Company
Shifamed
Shifamed is a progressive medical technology incubator that combines human-centered design.
201-500 employees
H1B Sponsorship
Shifamed has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (4)
2021 (2)
Funding
Current Stage
Growth StageLeadership Team
Claudio Argento
CTO
Mariam Maghribi
Chief Business Officer
Recent News
2025-10-01
2025-08-13
Company data provided by crunchbase