Sr. Quality Engineer

Shifamed • Los Gatos, CA

17d

About The Position

Our Senior Quality Engineer will proactively drive quality and compliance in design and development in a collaborative way. This position represents an exciting opportunity to join an innovative and high performing team and influence the design and development in early stages. As a key member of our team, you will actively drive design controls, design history file, risk management, design verification protocols and testing. This position also represents an opportunity to influence the design selection, optimization, specifications, and test development. You will enable patient safety, quality, and reliability in the early designs. This position will also play an active role in developing quality management system and ensure QMS compliance adherence.

Requirements

• 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.
• 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.

Nice To Haves

• 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.
• Experience in the medical device industry with electromechanical products and/or interventional cardiology products is preferred.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees