Director, Quality Engineering Operations, Disposables & Accessories

Company Overview

PROCEPT Bio Robotics is dedicated to putting the patient first and revolutionizing treatment for benign prostatic hyperplasia (BPH) through innovation in surgical robotics. Our mission is to improve the quality of life for patients and provide surgeons with effective, cutting‑edge solutions. We invest in our people, nurturing a culture of curiosity, ingenuity, and collaboration. Our live induction program and management development initiatives equip employees with the skills and confidence to drive continuous career growth and bring transformative technologies to the market.

As PROCEPT expands globally, you will lead production quality control and quality engineering for disposables and accessories. You will provide management oversight, support compliance activities under our Quality Management System (QMS), and grow a high‑performance team that collaborates with cross‑functional partners to satisfy quality engineering requirements.

• Lead quality engineering teams supporting Disposables & Accessories operations.
• Recruit, retain, and develop a high‑performance team; manage job descriptions and on‑boarding.
• Build relationships with internal and external partners to support strategic business initiatives.
• Lead completion of departmental activities, setting objectives and goals.
• Execute improvement projects, including Lean/Six Sigma and DFX initiatives on the manufacturing line.
• Manage quality budgeting, planning, and target setting.
• Support supplier quality and design transfer of new products into manufacturing.
• Drive R&D/Advanced Manufacturing Engineering to deliver manufacturing designs with high process capability.
• Maintain awareness and practice of employee safety standards.
• Develop and execute overall quality engineering strategy for a product line or platform.
• Plan, risk‑mitigate, and resolve program risks and issues.
• Collaborate with multi‑disciplinary teams (Legal, Regulatory, Operations, Clinical Affairs, Marketing, Quality).
• Oversee transition to manufacturing and field service support as needed.
• Travel to suppliers or contract manufacturers when required.

• B.S. in Science, Engineering, or equivalent; M.S. preferred.
• 8+ years of experience in the medical device industry, with at least 5 years in leadership roles.
• Experience with ISO 13485, FDA QSR, ISO 14971, MDD, EU MDR, and Canadian Medical Device Regulations.
• Familiarity with structured design processes and regulatory approval requirements.
• Strong project management skills using tools such as Smartsheet.
• Proficient in Microsoft Office and Microsoft Excel; familiarity with Minitab is a plus.
• Experience with electronic QMS and software/image devices is desirable.
• Excellent oral and written communication, interpersonal, and influence skills.
• Ability to balance hands‑on tasks, team management, and budgeting.
• Strong analytical and problem‑solving abilities; proficient in interpreting data and applying quantitative methods.

USD 220,500 – 259,410 per year.