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Senior NPI Manufacturing Engineer

Senior NPI Manufacturing Engineer

Ring IncSan Jose, CA, United States
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Overview

Company Overview

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

The Opportunity That Awaits You :

We are growing our operations team and have an excellent opportunity for a Senior NPI Manufacturing Engineer who can bring creativity, experience, and project skills at this key time. You will develop and transfer manufacturing processes for new product introductions, product changes, and enhancements. 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. Using 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 is a chance to make a real difference in healthcare.

The Day-to-Day

Responsibilities

  • Collaborate with R&D during early product design to influence architecture and ensure manufacturability, serviceability, and process repeatability.
  • Provide Design for Manufacturing (DFM), Design for Assembly (DFA), Design for Reliability (DFR), and Design for Serviceability (DFS) recommendations and ensure their implementation during new component and assembly design reviews.
  • Represent the operations perspective for new product activities from development through production release.
  • Create process validation protocols, conduct process optimization studies, perform verifications and validations, and generate reports.
  • Own and maintain up-to-date process documentation, including Manufacturing Instructions, Standard Work, PFMEAs, and Control Plans for new product design projects.
  • Lead design transfer efforts including process validation (IQ, OQ, PQ), equipment qualification, and documentation (manufacturing instructions, control plans, PFMEAs).
  • Collaborate to develop process CTQ indicators.
  • Generate custom fixture CAD models and drawings; coordinate fixture fabrication, testing, and qualification.
  • Drive projects as an NPI leader through schedule management, cross-functional collaboration, conflict resolution, and completion of design transfer deliverables.
  • Communicate project status and actions to internal partners.
  • Train, develop, and provide work direction to operators and technicians.
  • Maintain trained status for compliance with PROCEPT BioRobotics Quality Management System and regulatory requirements; adhere to Quality and EHS policies.
  • Travel up to 10% domestically and internationally as needed.

Qualifications

The Qualifications We Need You to Possess

  • Bachelor’s degree in engineering (Mechanical, Electrical, or related field) with 3+ years of experience, or Master’s degree with 2+ years 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 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 ISO 9000, FDA QSR 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) and strong computer skills in Microsoft Office.
  • The Qualifications We Would Like You to Possess
  • 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 deadlines and manage multiple tasks.
  • Software / Firmware / Hardware experience in large electromechanical systems; robotics experience a bonus.
  • Six Sigma Black Belt certification and demonstrated process, cost, or quality improvements.
  • Familiar with DFM / DFX evaluation of part design, material choice, dimensional specs, manufacturing methods to reduce part count and cost.
  • Compensation and Benefits

    $100,000 - $118,000 a year

    This position also includes an annual bonus of 10%, RSUs at offer, and flexible time off.

    Culture and Benefits

    Understanding PROCEPT's Culture

    At PROCEPT, we believe every person matters—every employee, patient, and caregiver. We are committed to innovation with pathological optimism, humility, and engagement. We emphasize curiosity, ingenuity, and conviction in the power of technology to transform lives.

    We offer a live induction program that builds cross-functional teams, an immersive history, executive leadership sessions, and a focused mission orientation. Our management program develops managers who collaborate, grow, and contribute in a challenging yet supportive environment.

    We aim to give people their lives back, pursuing a work / life blend where you can be proud to share your professional life with family and friends.

    An opportunity at PROCEPT BioRobotics is more than a job—it’s a chance to join a community making a difference.

    Benefits of Working at PROCEPT

    PROCEPT offers comprehensive health and wellness benefits, including full medical coverage, wellness programs, on-site gym, 401(k) with employer match, disability coverage, life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and more.

    Legal and Work Standards

    EQUAL EMPLOYMENT OPPORTUNITY STATEMENT

    PROCEPT BioRobotics is an equal opportunity employer committed to diversity and inclusion. We prohibit discrimination and harassment on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or other protected statuses in accordance with laws.

    PAY RANGE TRANSPARENCY

    PROCEPT is committed to fair compensation practices. The pay range represents base salary for non-commissionable roles or on-target earnings for commissionable roles. Actual compensation depends on factors such as skills, experience, certifications, and location. The package may include bonuses, equity, and listed benefits.

    WORK ENVIRONMENT

    We provide training for, and expect compliance with, the PROCEPT Quality Management System and related Quality & EHS policies.

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    Senior Manufacturing Engineer • San Jose, CA, United States