Principal Quality Engineer

Jupiter Endovascular • Menlo Park, CA

1d • $160,000 - $175,000 • Onsite

About The Position

The Principal Quality Engineer position supports and executes development quality and design assurance activities within the product development organization. In addition, the Principal Quality Engineer will support the remaining quality assurance and regulatory staff, identify and communicate issues pertaining to quality and regulatory, recommend resolutions; and upon leadership alignment, lead design assurance activities in collaboration with cross functional and/or matrix teams.
This is an in-office role.

Requirements

• BS in Engineering or related sciences is required. Preferred MS in Engineering or another technical discipline.
• Minimum of 10 years of experience in medical devices is required. Catheter and/or capital equipment experience is preferred.
• Strong understanding of FDA 21CFR Part 820 and ISO 14971:2019 Application of Risk Management.
• Working experience in full-lifecycle, regulated engineering programs and processes.
• Structured medical device product development experience in requirements- driven engineering, documentation, rigorous verification, etc.
• Able to clearly identify, define, and communicate technical, process, and quality related issues or improvements with internal and external personnel.
• Able to create and execute training for team members on quality processes and systems.
• Excellent written and verbal communication, presentation, relationship management and negotiation skills.
• Proven successful project management skills that drive continuous evolution while maintaining strict attention to detail.
• Ability to interact professionally and effectively with external and internal personnel levels including proactively escalate issues to appropriate levels of management in the organization.
• Excellent problem-solving, organizational, analytical, and critical thinking skills including high discretion/judgment in decision making.
• Ability to work and excel within a fast-paced, dynamic, and continuously changing work environment while demonstrating a sense of urgency.
• Proven expertise in usage of MS Office Suite and eQMS systems preferred.

Responsibilities

• Directly responsible for ensuring QMS processes and product compliance with Product Development group, including Design Controls, Risk Management, early Production and Process Controls during Design Transfer, and Data Analysis.
• Lead the establishment of the Risk Management File and Usability Engineering related activities (FMEAs, Hazard Analysis, Risk Plans, Reports) for new product development, clinical investigation, and/or commercially released product per ISO 14971.
• Lead design quality activities for product development starting from requirements phase through development, Verification & Validation (V&V), standards review, and design transfer to commercialization phase activities.
• Participate in development and maintenance of the Medical Device File (MDF), which includes Design History Files (DHF) for each product family and associated Verification & Validation Plans and Reports.
• Mentor teams on Design of Experiments (DOE), hypothesis testing, problem solving techniques (5- whys, RCA, Ishikawa Cause and Effect "Fishbone" diagrams, etc.), experimentation, quality function deployment, measurement systems analysis, sample creation and selection, statistical techniques, gage R&R studies, inspection techniques, etc.
• Participate in regulatory activities, including PMA, FDA 510(k) and Technical Documentation File for CE mark under EU MDR creation, review and submission.
• Create or revise the company's Quality Management System procedures, instructions, forms and records to meet regulatory requirements.
• Prepare, review and approve Engineering and Document Change Orders.
• Participate in design transfer activities, including to in-house Operations and/or external Contract Manufacturers.
• Ability to effectively work with all levels of internal staff and external contractors and vendors / contract manufacturers, as needed.
• Additional responsibilities and duties, as assigned.

Benefits

• Work in a culture built on shared purpose, where passionate teammates support one another and stay motivated by improving patient lives.
• Thrive in a collaborative environment that values new ideas, gives everyone a voice, and offers professional growth and exposure across departments as the company enters an exciting phase of expansion.
• Earn competitive pay with performance incentives and equity opportunities.
• Enjoy comprehensive, top of the market medical, dental, and vision coverage focused on meaningful premium support and smart savings.
• Access meaningful benefits including a top tier 401(k) with a best in-class plan design which includes strong employer contributions, short and long-term disability, life insurance, commuter benefits, and wellness support.
• Take advantage of a healthy paid time off policy, company holidays, and an environment that encourages a healthy work-life balance.
• Strengthen relationships through shared experiences - from daily company-provided lunches and Thursday socials to monthly potlucks, company events, and volunteer opportunities that have a real impact in the community.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level