Senior NPI Manufacturing Engineer San Jose, CA

Company Overview

Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. We 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:

As we continue to grow and scale our operations team at PROCEPT, we have an excellent opportunity for a new Senior NPI Manufacturing Engineer who can bring their creativity, experiences, and project skills to the company at this key time in our growth. You will bring your experience and collaboration skills to develop and transfer manufacturing processes for new product introductions, product changes, and enhancements. As a Senior NPI Manufacturing Engineer you will be the key voice for manufacturing while interfacing with R&D to develop and transfer new products, designs, and processes into production, driving a culture of Design for Excellence. Utilizing your experience, critical thinking, and project management skills, you will organize and influence design selections, set design transfer strategies, and shepherd product changes into production and the field.

This isn't just any job—it's a chance to make a real difference in healthcare.

• Collaborate with R&D during early product design to influence architecture and ensure manufacturability, serviceability, and process repeatability
• Provide the team with Design for Manufacturing (DFM), Design for Assembly (DFA), Design for Reliability (DFR), and Design for Serviceability (DFS) recommendations, ensuring their implementation during new component and assembly design concept and detailed drawing reviews.
• The candidate will actively represent the operation teams perspective for new product activities through product development to production release.
• Create process validation protocols, conduct process optimization studies, conduct process verifications and validations, and generate verification and validation reports.
• Own and maintain up-to-date process documentation, including Manufacturing Instructions, Standard Work, PFMEAs, and Control Plans for the new product design projects.
• Lead design transfer efforts including process validation (IQ, OQ, PQ), equipment qualification, and documentation (e.g., manufacturing instructions, control plans, PFMEAs)
• Collaborated with team to develop process CTQ (Critical to Quality) indicators.
• Generate custom fixture CAD models and detailed drawings. Complete or coordinate fixture fabrication, testing, and qualification.
• Drive projects as an NPI leader through schedule creation/management, cross functional collaboration, conflict resolution, and design transfer deliverables completion.
• Communicate to internal partners on project status and actions.
• Train, develop, and/or provide work direction to operators and technicians
• Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance.
• May require up to 10% travel, domestic and international.
• 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’ Quality and EHS policies.

• Bachelor’s degree in engineering (Mechanical, Electrical, or related field) with 6+ years of experience, or Master’s degree in Engineering with 4+ years of experience in a regulated industry.
• Strong experience developing manufacturing processes, for Electromechanical assemblies.
• Background in medical device or capital equipment manufacturing within a regulated industry.
• Proven track record in NPI process development, DFx, and cross-functional project leadership
• Extensive experience with root cause analysis (RCA) and problem-solving for both technical and process issues.
• Experience with BOM creation, management, and change control.
• Preferred experience with Salesforce, QAD, or similar systems for BOM and change management.
• Familiarity with structured design processes (ISO 9000, FDA QSR) and regulatory approval requirements.
• Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO 13485.
• Proficiency with CAD software (SolidWorks or similar).
• Excellent computer skills with specific skills in Microsoft Office and proficient in SolidWorks.

• Experience supporting capital equipment medical device manufacturing.
• Experience transferring highly technical projects to production in a cross functional environment.
• Proficiency in DFx principles: DFM, DFT, DFQ, DFR, DFC.
• Ability to work to a deadline and to handle multiple tasks simultaneously.
• Software/Firmware/Hardware experience – in large Electromechanical systems (Robotics systems a bonus)
• Six Sigma Black Belt certification & project executed with significant process improvement, cost saving or quality improvement.
• Familiar with DFM/DFX - Evaluation of part design, material selection, dimensional specifications. manufacturing methods and ease of assembly to reduce part count, improve efficiency and lower cost.

$130,000 - $178,000 a year

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!

BENEFITS OF WORKING AT PROCEPT!

PROCEPT’s health and wellness benefits for employees are second to none in the industry. As an organization, one of our top priorities is to maintain the health and wellbeing of our employees and their families. We offer a comprehensive benefits package that includes 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, and many more!

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT

PROCEPT BioRobotics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization.

PAY RANGE TRANSPARENCY

Procept is committed to fair and equitable compensation practices. The pay range(s) for this role represents a base salary range for non-commissionable roles or on-target earnings for commissionable roles. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, relevant certifications and training, and specific work location. Based on the factors above, Procept utilizes the full width of the range. The total compensation package for this position may also include eligibility for annual performance bonus, equity, and the benefits listed above.

WORK ENVIRONMENT

We’ll provide you training for, and ask you to maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. We would also ask you to understand and adhere to the PROCEPT BioRobotics Quality & EHS policies.