Manager, Equipment and Automation

PROCEPT BioRobotics Corporation; San Jose, Northern (CA, KY); Hybrid; USD 165,000 - 194,000; Full time

Job summary

PROCEPT BioRobotics Corporation is seeking an experienced Equipment Engineering leader in San Jose, CA to design, qualify, and deploy manufacturing and test systems for surgical capital equipment. Lead a high-performing team, define strategy, and collaborate with R&D, NPI, Operations and suppliers to deliver robust automation from concept to production release.

The role requires 7+ years in medical device manufacturing, strong cross-functional leadership, GMP/ISO 13485 knowledge, and exceptional

Qualifications

• Bachelor of Science in Electrical, Mechanical or Software Engineering.
• Minimum 7 years’ experience in Medical Device manufacturing.
• Hands-on Equipment Engineering experience supporting manufacturing.
• Experience in a medical device company or regulated business.
• Strong organizational skills and attention to detail.
• Exceptional oral and written communication skills.
• Leadership in cross-functional collaboration including conflict resolution and negotiation.
• Onsite availability for 5 days per week.

Responsibilities

• Establish and lead a team to design and build equipment for manufacturing and testing of surgical capital equipment.
• Lead continuous improvement, manage projects, and report team performance metrics.
• Develop and deploy equipment and automation solutions with R&D/NPI teams.
• Improve design for test and validate with external suppliers.
• Coordinate cross-functional communication to meet critical deliverables and milestones.
• Establish standards for equipment design, performance, validation and maintenance.
• Plan and execute validation activities (IQ/OQ/PQ) for new equipment.
• Maintain BOMs and spare equipment; manage configurations.
• Drive FAT and factory acceptance processes and analyze yield improvements.

Skills

Medical device manufacturing

Cross-functional leadership

Excellent communication

GMP/ISO 13485 knowledge

Problem solving

Onsite 5 days

Scrum / Agile

Education

Bachelor of Science in Electrical/Mechanical/Software Engineering

Tools

Excel

Minitab

Job description

Company Overview

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. Understanding PROCEPT's Culture At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers. And this doesn’t happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one‑of‑a‑kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances. An opportunity at PROCEPT BioRobotics won’t just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!

The Opportunity That Awaits You:

Are you ready to build the equipment, automation, and engineering capabilities behind the next generation of surgical technology? This is an opportunity to establish and lead a high-performing equipment engineering team responsible for designing, qualifying, and deploying the manufacturing and test systems used to produce innovative surgical capital equipment. You will define the equipment and automation strategy, establish engineering and validation standards, and collaborate with R&D, NPI, Operations, and external suppliers to bring robust solutions from concept through IQ/OQ/PQ and production release. Your leadership will directly improve manufacturing yield, test coverage, diagnostic capability, productivity, and error-proofing while ensuring compliance with GMP and other medical-device requirements. We are looking for an experienced, hands‑on engineering leader who combines deep technical expertise with strong cross‑functional leadership and is excited to build a team, solve complex equipment challenges, and help shape the future of our manufacturing operations.

What Your Day-To-Day Will Involve:

• Establish and lead a team to design and build equipment for use in manufacturing and testing of surgical capital equipment
• Lead a team through continuous improvements and project executions and periodically report key metrics on the team’s performance.
• develop and deploy solutions.
• Work with the R&D and NPI teams to identify and incorporate design for test optimizations.
• Facilitate communication and interaction among cross functional team members to ensure adherence to critical deliverables and milestones.
• Develop relationships with external automation and tooling suppliers to increase capacity to Establish standards for equipment design, performance, validation and maintenance.
• Plan and execute test method and test equipment validations.
• Write specifications for test equipment and leverage external partners to build and validate the equipment Oversee product test specifications and applicable test equipment requirements for new products.
• Maintain BOMs for test fixtures, tools, or aids.
• Maintain spare equipment, hardware/software, and computer configurations.
• Determine the root cause of equipment and system test failures.
• Develop and execute equipment/automation strategy in support of overall Operations strategy.
• Identify, design, qualify, document, and implement automation test and assembly equipment solutions to be used in manufacturing.
• Document all aspects of the equipment, including its requirements, design, operation, and qualification in compliance with Good Manufacturing Processes (GMP).
• Perform design reviews for new equipment and tooling developed.
• Execute equipment design and process verification/validation, including IQ/OQ/PQ activities to allow production release of new equipment.
• Drive continuous improvement projects to increase manufacturing yields, improve test coverage, diagnostic capability, productivity, and error proofing.
• Utilize statistical tools to develop reports of process performance and identify areas of manufacturing improvement.
• Draft and execute factory acceptance testing(FAT).
• Establish design requirements and specifications for automated testing

The Qualifications We Need You to Possess

• Bachelor of Science of electrical, mechanical or software engineering
• Minimum 7 years’ experience in Medical Device manufacturing
• Prior hands‑on Equipment Engineering experience supporting manufacturing.
• Experience working in a medical device company or other regulated business.
• Strong organizational skills, detail oriented.
• Exceptional oral and written communication skills.
• Demonstrated leadership skills in building cross‑functional collaboration including conflict resolution, assertiveness, and negotiation skills.
• Support onsite for 5 days in person

The Qualifications We Would Like You to Possess

• Experience driving a team using Scrum Agile framework
• Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.
• Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred)

Pay Range for this role:

$164,500 to $193,530

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. At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers. And this doesn’t happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one‑of‑a‑kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances. An opportunity at PROCEPT BioRobotics won’t just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!