PROCEPT BioRobotics · 2 weeks ago
Design Quality Engineering Manager, Surgical Instruments
San Jose, CA
Full-time
Onsite
Senior Level
$162K/yr - $191K/yr
5+ years expPROCEPT BioRobotics is committed to revolutionizing treatment for benign prostatic hyperplasia through innovation in surgical robotics. The Design Quality Engineering Manager will lead the capital quality engineering team, overseeing design quality deliverables and ensuring compliance with international quality system standards for their robotic surgery platforms.
Health CareManufacturingMedical DeviceRobotics
Responsibilities
The Design Quality Engineering Manager leads the ongoing quality deliverables for integration and development of multiple engineering disciplines for our robotic surgery platforms
This role will oversee the Design Quality team by developing and implementing in‐depth strategies and project plans to improve product qualification for robotic related single use devices, consumables, and accessories
The candidate will work closely with the R&D and Manufacturing on Design quality assurance activities to ensure alignment across the organization
The candidate will be responsible for developing design quality assurance and reliability strategies for worldwide approval to introduce new and/or modified products to market in compliance with the company's Quality Management System, 21CFR820, ISO 13485 and other applicable international quality system standards
Support new product development and design changes to existing products in ensuring compliance with company’s Quality System
Lead Risk Management activities including improving the risk management process
Support design, test, and inspection method development, and assist with design verification and validation testing
Develop and implement product quality plans, product specifications, risk management plans to ensure high degree of assurance that specific design and processes will consistently and continually produce a product that meets specifications and critical to quality attributes
Develop and maintain procedures for UDI requirements and registration of devices
Update or submit product data information and work with third party service provider
The Design Quality Engineering Manager will be responsible for the hiring, development, and performance management of the Design Quality team
Create, apply, and monitor performance metrics for personnel, product, and processes
Collaborate cross functionally to Identify and implement projects that include, but are not limited to, reliability improvements, process efficiency, product manufacturability and cost reductions
Plan annual budget to ensure resources are adequate to execute approved projects and goals
Provide leadership, coaching and development plans for all direct reports to maintain an engaged and productive workforce
Drive projects through cross functional collaboration, timeline, and schedule management
Prepare and issue timely status updates on active projects for review by Senior Management
Assure compliance to all company policies, standard operating procedures and recognized domestic/international standards
Oversee the product development process and deploy applicable standard operating procedures for new product development and design changes to existing products
Support corrective and preventive action process for design and quality assurance process related CAPA
Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance
Understand and adhere to the PROCEPT BioRobotics EHS policy
Qualification
Required
Bachelor's degree in STEM or Quality related education or an engineering discipline required
Minimum of 5 years of experience working in medical device industry
Must have working knowledge of CFR 820, ISO 13485, ISO 14971, IEC 60601-1
Strong understanding of ISO 14971
Have working knowledge of sterilization, biocompatibility, and transit/shelf-life standards
Must be detail oriented, well organized and have excellent communication skills. Must work well with team
Must be able to accomplish objectives with minimal supervision
Experience in conducting product Investigations
Demonstrated reasoning ability to apply principles of logical or scientific and critical thinking
Demonstrated ability to be a proactive and collaborative leader in a dynamic operations and engineering environment. This individual possesses a bias toward action and results (no stones left unturned)
Able to multi‐task, establish clear expectations, set objectives and deliver results within tight deadlines
Must be able to work in a dynamic, fast‐paced environment with strong ability to establish technical and professional credibility and demonstrate MUST‐DO attitude
Must be able to manage and resolve conflicting product and project requirements and be a strong team player with ability to collaborate across functional areas
Expected to present design quality related topics in the front room for regulatory audits (FDA, MDSAP, MDR)
Background in electromechanical and software devices
Must have a solid understanding of statistical processes and techniques
Ability to read, analyzes, and interprets general business periodicals, professional journals, technical procedures, or governmental regulations
Ability to write reports, business correspondence, and procedure manuals
Ability to effectively present information and respond to questions from other internal groups, clients, customers, and the general public
Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Preferred
Master's degree preferred
Experience leading technical teams and/or managerial supervisory experience preferred
ASQ CQE, CQA, Black Belt Six Sigma certification a plus
Benefits
Full medical coverage
Wellness programs
On-site gym
A 401(k) plan with employer match
Short-term and long-term disability coverage
Basic life insurance
Wellbeing benefits
Flexible or paid time off
Paid parental leave
Paid holidays
Company
PROCEPT BioRobotics
PROCEPT BioRobotics is a surgical robotics company that develops water-based robotic systems for prostate surgery.
501-1000 employees
H1B Sponsorship
PROCEPT BioRobotics 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
2025 (24)
2024 (7)
2023 (27)
2022 (16)
2021 (4)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$820.34MKey Investors
CIBC Innovation BankingFidelityViking Global Investors
2024-10-29Post Ipo Secondary· $175M
2023-08-01Post Ipo Equity· $150M
2022-10-10Post Ipo Debt· $52M
Leadership Team
Mohan F. Sancheti
Vice President Operations
Recent News
thefly.com
2025-12-09
2025-11-07
PROCEPT BioRobotics
2025-11-05
Company data provided by crunchbase