Senior Process Engineer Orthopaedics

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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.

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About Orthopaedics

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding the possibilities of Orthopaedics Ready to join a team thats reimagining how we heal 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.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be required regulatory approvals and other customary conditions and approvals.

Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Position Overview

The Senior Process Engineer owns and optimizes assigned manufacturing value streams to ensure safe compliant and costeffective production of medical this role you will provide strategic technical leadership direct complex process development and validation programs lead multi-functional continuous improvement initiatives and influence longterm 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 handson engineering leadership to achieve key business metrics (HSE Quality Supply Cost) across assigned value streams.

• Lead endtoend 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 highimpact 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 problemsolving and risk assessment tools (8D FMEA DFMEA Six Sigma) to identify root causes and implement robust longterm corrective actions.

• Lead cost reduction and productivity initiatives (scrap/rework reduction throughput improvements consumables optimization) with measurable savings and sustainability impacts.

• Participate in daytoday 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

• Bachelors 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.

• Proven experience supporting NPI scaleup and transfer activities.

Preferred Qualifications & Experience

• Training or certification in Six Sigma (Black/Green Belt) Lean or equivalent continuous improvement methodologies.

• Proficiency in CAD/CAM and experience specifying tooling fixtures gauges and special equipment.

• Project management experience including planning budgeting coordination and supplier management.

• Familiarity with calibration maintenance practices and working closely with inhouse maintenance teams.

• Knowledge of regulatory requirements and submissions applicable to medical device manufacturing.

• Prior experience mentoring/leading emerging engineers or small technical teams.

Key Competencies

• Strategic and analytical problem solver with datadriven decisionmaking skills.

• Structured problem solver with a focus on root cause and sustainable corrective actions.

• Strong multi-functional collaborator and influencer (Operations Quality R&D Suppliers); able to represent Operations in governance and regulatory settings.

• Excellent written and verbal communication skills for technical content and collaborator updates.

• Project organisation prioritisation and execution with the ability to drive complex actions to timely closure.

• Continuous improvement attitude with measurable focus on cost quality and supply stability.

• Commitment to Health Safety and Environmental (HSE) practices and regulatory compliance.

#LI-Fully Onsite

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