Staff Product Development Engineer: Surgical Robotics – OTTAVA

Johnson & Johnson•Santa Clara, CA

12h•Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. The MedTech Surgery team is fueled by innovation at the intersection of biology and technology, developing the next generation of smarter, less invasive, more personalized treatments. This team delivers surgical technologies and solutions to surgeons and healthcare professionals globally, helping to treat prevalent conditions such as obesity, cardiovascular disease, and cancer. The Staff Product Development Engineer supports the OTTAVA Surgical Robotic Platform. This role is part of a team of engineers, designers, and technical specialists operating at the forefront of innovation in the medical device industry. As a Staff Product Development Engineer, you will play a critical role in shaping the New Product Development (NPD) and New Product Introduction (NPI) pipeline, driving technical direction and solutions that significantly impact patient care. The Development Engineering organization partners closely with NPD teams, Manufacturing, Quality, and suppliers to define and deliver robust component designs and scalable manufacturing processes that meet or exceed product, quality, and regulatory requirements. In this role, you are recognized as a technical authority and strategic contributor, working across multiple programs or complex subsystems to develop sophisticated, highly regulated medical devices. Staff level expectations include operating with a high degree of autonomy, influencing technical decisions beyond an individual project, and resolving complex, ambiguous engineering challenges that span disciplines. You are expected to demonstrate deep electrical and mechanical engineering expertise, provide technical leadership through design reviews and critical problem solving, and proactively identify risks and opportunities across the development lifecycle. Success in this position requires the ability to influence without authority, communicate effectively across engineering teams, suppliers, and management, and align technical solutions with business and manufacturing objectives. The Staff Product Development Engineer sets technical direction within their domain, mentors less experienced engineers as needed, and thrives in a fast paced, dynamic environment where judgment, accountability, and collaboration are essential.

Requirements

Minimum B.S. (Mechanical, Electrical, or other related Engineering field equivalent) and 8 years of industry experience.
Engineering experience in either mechanical, electro-mechanical, opto-mechanical, or electro-optical products and components or equipment.
Experience in Design for Manufacturing or Assembly (DFM/A) around injection molding, machining, and optical equipment.
Proficiency in 3D CAD (SolidWorks or Creo) and GD&T per ASME Y14.5.
Strong understanding of cost implications on design requirements, alongside broad engineering knowledge in developing and implementing manufacturing processes that meet or exceed product requirements.
Experience working closely with external or third-party suppliers.
Knowledge and demonstrated application of regulated medical device development processes, standards, and guidelines, including but not limited to 21 CFR 820, ISO 13485, ISO 14971, and IEC 60601.
Measurement Systems Analysis experience (e.g., GR&R).
Statistical Analysis knowledge (e.g., Design of Experiments (DOE), Process Stability/Control/Capability) and PFMEA.
Understand equipment concept creation, review approval, build, runoff, FAT, software validation, IQ, OQ, and PQ road map requirements.
Proven interpersonal and communication skills, with the ability to work successfully in a team environment.
Strong technical communication skills and proven ability to work independently.
Up to 30% domestic and international travel.

Nice To Haves

Advanced Degree.
Solid understanding of regulatory requirements regarding the design, build, and release of medical devices, worldwide.
Experience designing, developing, and testing the manufacturing of electromechanical, fiber, or laser equipment and systems, including test and process development.
Experience in Cost Engineering: Demonstrated experience in leading cost engineering initiatives, along with a solid track record of managing complex design projects with a focus on financial performance and strategic cost reductions.
Knowledgeable about medical-specific assembly technologies, equipment supplier base, and the capabilities of the suppliers.
Process Excellence Six Sigma knowledge or certification.
Test methods development (TMD) & Test methods validation (TMV) experience.
Experience with one or more of the following: laser welding, riveting, laser etching, soldering, pressing, joining, extrusion, over molding, coating, and/or design for assembly experiences.

Responsibilities

Partner with internal teams and external suppliers to plan, develop, qualify, and stabilize component, equipment, and manufacturing processes for NPD projects.
Lead cross functional collaboration with R&D, Manufacturing, and Suppliers to implement robust manufacturing solutions using DFM, DFA, and Design to Cost principles.
Lead and conduct tolerance stack-up, GD&T and FEA analysis to ensure designs are robust and manufacturable at volume.
Drive cost effective technical solutions through design simplification, material selection, and process improvements without compromising quality or performance.
Lead formal design reviews by evaluating technical feasibility, manufacturability, and cost trade offs to influence product design decisions.
Act as a liaison across R&D, Product Management, Quality, Manufacturing, and suppliers to ensure the voice of manufacturing is embedded in design.
Support Design Transfer to enable a smooth, compliant transition into manufacturing.
Apply advanced engineering principles, manufacturing techniques, and statistical analysis to resolve complex technical challenges and establish new methods and standards.
Lead PFMEAs, process characterization, and control strategies in compliance with GMP.
Oversee engineering builds and pilot runs, performing root cause analysis and driving corrective actions.
Manage project deliverables and control design changes to minimize impact to assembly processes.