Senior Process Engineer - Orthopaedics

This job is with Johnson & Johnson, an inclusive employer. 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.

About Orthopaedics: Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

Position Overview: The Senior Process Engineer owns and optimizes assigned manufacturing value streams to ensure safe, compliant, and cost‑effective production of medical devices. In this role you will provide strategic technical leadership, direct complex process development and validation programs, lead multi-functional continuous improvement initiatives, and influence long‑term process and equipment strategy. You will mentor junior engineers, represent Engineering in governance and regulatory forums, and drive initiatives that improve quality, supply continuity, and cost performance.

Key Responsibilities:

• Provide hands‑on engineering leadership to achieve key business metrics (HSE, Quality, Supply, Cost) across assigned value streams.
• Lead end‑to‑end process development and industrialization for complex processes and New Product Introductions (NPI), ensuring scalable, robust, and validated manufacturing processes.
• Develop, plan, and implement complex validation strategies and protocols including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ); review and approve validation work and ensure regulatory compliance.
• Own and drive closure of high‑impact quality actions (Audit Actions, NCRs, CAPAs), prioritize resources, and ensure sustained corrective and preventive measures.
• Serve as the primary technical collaborator with R&D, Quality, Supply Chain, Maintenance, and external suppliers to specify tooling, fixtures, gauges and special equipment.
• Define equipment and process requirements, lead solving of recurring issues, and partner with maintenance and calibration to improve equipment reliability and uptime.
• Apply and coach structured problem‑solving and risk assessment tools (8D, FMEA, DFMEA, Six Sigma) to identify root causes and implement robust long‑term corrective actions.
• Lead cost reduction and productivity initiatives (scrap/rework reduction, throughput improvements, consumables optimization) with measurable savings and sustainability impacts.
• Participate in day‑to‑day operations governance (pulse walks, production reviews) and bring up/handle operational risks to senior leadership as needed.
• Prepare, review and maintain technical content, manufacturing specifications, and change controls; ensure design and process changes follow the Quality Management System and regulatory requirements.
• Provide technical mentorship to engineers and technicians, champion continuous improvement culture, and support capability development across the organization.
• Contribute to capital project planning, budgeting, and prioritization for equipment upgrades and process automation.

Required Qualifications & Experience:

• Bachelor's degree or equivalent experience in Engineering (or equivalent).
• Demonstrated ability in manufacturing/process engineering.
• Demonstrated experience leading validation activities including IQ, OQ and PQ for equipment, processes and systems.
• Proven track record managing Audit Actions, NCRs and CAPAs within a Quality Management System.
• Strong experience in structured problem solving and root cause analysis.
• Excellent technical content skills (specifications, validation protocols, change control).
• Experience leading multi-functional teams and influencing collaborators at multiple levels.