Senior Quality Engineer - Capital Equipment

Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.

The Opportunity That Awaits You:    

Do you want to be part of an innovative, cutting-edge technology, robotics company that is changing how BPH is treated?  Are you looking to be part of an enthusiastic, driven, passionate and challenging team, who continuously learn from one another?  Are you a leader who wants to make a difference and improve processes? Are you detailed oriented? At PROCEPT BioRobotics you will have an opportunity to contribute and greatly support our continuous improvement philosophy by being part of our Capital Medical device Quality Engineering team as a Senior Quality Engineer. This position has a unique impact on the quality and reliability of our devices. You will work with cross-functional teams to maintain and improve the Quality System within the requirements of FDA's Quality System Regulation (QSR), ISO 13485 (ISO) and EU MDR. Being detail and solution-oriented, proactive, and self-managed will assist in the success of this position.
 

•    Participate in and support new product design transfer through commercialization and design change transfers to existing products in ensuring compliance with company’s Quality System with primary focus on electrical and software systems, evaluating reliability and ensuring quality requirements are met.
•    Facilitate, or Support risk management activities specifically process FMEA and participate in the formal design and production release process for medical devices.
•    Ensure appropriate inspection and testing strategies for electrical assemblies, firmware loading, and system-level production acceptance testing.
•    Represent Quality function within Capital Equipment Production and Service Operations, ensuring standards are maintain across the product lifecycle.
•    Establish and maintain master validation program, including site and individual products and process master validations (IQ/OQ/PQ) activities 
•    Partner with manufacturing engineers to review and improve manufacturing documentation to ensure manufacturability, serviceability, testability, reliability, and compliance with product requirements 
•    Define and support for in-process inspections, and release testing, including statistical sampling strategy and test methods. 
•    Audit, maintain, and ensure accuracy of the Device Master Record (DMR) or Medical Device File
•    Ensure production personnel maintain compliance with training requirements and quality procedures.
•    Support regulatory inspections and notified body audits.
•    Support continuous improvement initiatives through failure investigations, root cause analysis, and resolution of non-conformances.
•    Contribute to and support the Corrective and Preventative Action (CAPA) Program, complaint investigations ensuring timely investigation, corrective actions, and effectiveness verification.
•    Participate in supplier quality activities, including material issue resolution, coordination of Material Review Board (MRB) decisions for non-conforming products. 
•    Collaborate with Supplier Engineering to resolve supplier-related quality issues. 
•    Maintain training and compliance with all aspects of the PROCEPT BioRobotics Quality Management System.
•    Understand and adhere to the PROCEPT BioRobotics Quality and Environment Health and Safety (EHS) Policies.

• Minimum 5 years with a Bachelor's degree or 3 years and a Master’s degree preferably in an engineering or scientific discipline from a four-year college or university (e.g. Biomedical/Electrical)
• 3-5+ years related experience in quality, manufacturing, or engineering in a regulated environment (medical device preferred).
• Background in electromechanical and embedded software devices.
• A working knowledge of the FDA Quality System Regulation CFR820, ISO 13485, ISO 14971, IEC62304.
• Must be detail-oriented with strong written and oral communication skills.
• Familiarity with test methods process verification, and capital production
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.
• Must have a working knowledge of statistics.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
• Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists

 

• Medical Device or Class II device experience preferred, will consider experience from other regulated industries such as pharmaceutical, military or nuclear.
• EU Medical Device Directive is a plus