Staff Product Development Engineer: Surgical Robotics – OTTAVA

Johnson & Johnson • Santa Clara, CA

1d • Onsite

About The Position

At Johnson & Johnson, the Staff Product Development Engineer supports the OTTAVA Surgical Robotic Platform within the MedTech Surgery team. This role is at the forefront of innovation in the medical device industry, playing a critical part in shaping the New Product Development (NPD) and New Product Introduction (NPI) pipeline. The engineer drives technical direction and solutions that significantly impact patient care by partnering with NPD teams, Manufacturing, Quality, and suppliers to define and deliver robust component designs and scalable manufacturing processes. As a recognized technical authority and strategic contributor, the Staff Product Development Engineer operates with a high degree of autonomy, influences technical decisions across multiple programs or complex subsystems, and resolves ambiguous engineering challenges. The role requires deep electrical and mechanical engineering expertise, technical leadership in design reviews and problem-solving, and proactive identification of risks and opportunities throughout the development lifecycle. Success hinges on the ability to influence without authority, communicate effectively across various teams and suppliers, and align technical solutions with business and manufacturing objectives. The Staff Product Development Engineer also sets technical direction within their domain and mentors less experienced engineers.

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 required.

Nice To Haves

• Advanced Degree.
• 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.
• Solid understanding of regulatory requirements regarding the design, build, and release of medical devices, worldwide.

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 tradeoffs 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior