Process Engineer

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

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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 Process Engineer is responsible for owning and improving assigned manufacturing value streams to ensure safe compliant and costeffective production of medical devices. This role provides handson technical support leads process development and continuous improvement initiatives and collaborates across Operations Maintenance Quality R&D and suppliers to maintain process stability and supply continuity. The incumbent will execute validation activities including Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) for equipment processes and systems drive timely closure of quality actions (Audit Actions NCs CAPAs) and apply structured problemsolving tools to implement robust corrective and preventive measures.

Key Responsibilities

Provide handson engineering support to achieve key business metrics (HSE Quality Supply Cost) for assigned value stream processes.

Lead process development and improvement activities to create stable capable and validated manufacturing processes.

Plan prepare and execute validation activities including Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) for equipment processes and systems ensuring documentation is complete and compliant with the Quality Management System.

Manage quality actions and corrective activities (Audit Actions NCRs CAPAs) to timely closure and sustained resolution.

Support NPI activities and collaborate with crossfunctional teams and external vendors on tooling fixtures gauges and special equipment.

Work closely with inhouse maintenance and calibration teams to define requirements support troubleshooting and improve equipment performance.

Apply structured problemsolving and root cause analysis tools (8D FMEA Six Sigma etc.) to investigate issues and implement robust corrective and preventive actions.

Deliver cost reduction initiatives such as scrap reduction rework minimisation and consumables optimisation.

Participate in daytoday operations (pulse walks production support) and ensure timely closure of operational actions.

Prepare and maintain technical documentation and manufacturing specifications for process steps and ensure changes follow change control and validation requirements.

Ensure all engineering activities comply with regulatory quality and safety requirements.

Required Qualifications & Experience

Bachelors degree in Engineering (or equivalent) or significant relevant manufacturing engineering experience

Minimum 2 years experience in similar engineering role

Practical experience in a regulated manufacturing environment (medical device experience preferred)

Demonstrated experience executing validation activities including Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) for equipment processes and systems

Proven experience managing Audit Actions NCs and CAPAs within a Quality Management System

Problem solving experience using structured tools (e.g. 8D root cause analysis)

Strong technical documentation skills (specifications validation protocols change control)

Preferred Qualifications & Experience

Proficiency in CAD/CAM and working with tooling fixtures and gauges

Knowledge of regulatory requirements applicable to medical device manufacturing

Training or certification in Six Sigma Lean or equivalent continuous improvement methodologies

Experience with FEA DFMA FMEA or other design/process risk assessment tools

Proven track record of delivering NPI support and equipment/process introductions

Project management experience including planning coordination and supplier management

Familiarity with calibration maintenance practices and working with in-house maintenance teams

Key Competencies

Strong analytical and data driven decision making skills

Expertise in validation strategy and execution (IQ/OQ/PQ)

Structured problem solver with attention to root cause and long-term corrective actions

Effective cross functional collaborator and influencer (Operations Quality R&D Suppliers)

Excellent written and verbal communication skills for technical documentation and stakeholder updates

Project organisation and prioritisation with ability to drive actions to timely closure

Continuous improvement mindset with focus on cost quality and supply stability

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

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