Senior Process Engineer – Orthopaedics

The Senior Process Engineer owns and optimizes assigned manufacturing value streams to ensure safe, compliant, and cost‑effective production of medical devices. This role provides strategic technical leadership, directs complex process development and validation programs, leads continuous‑improvement initiatives, and influences long‑term process and equipment strategy. The engineer mentors junior staff, represents Engineering in governance and regulatory forums, and drives initiatives that improve quality, supply continuity, and cost performance.

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.
• Proven experience supporting NPI, scale‑up 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 in‑house 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 data‑driven decision‑making 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.

Required Skills

• Continuous Improvement
• Process Validation
• Quality Validation

Preferred Skills

• Analytical Reasoning
• Computerized Equipment Skills
• Emerging Technologies
• Gemba Kaizen
• Issue Escalation
• Lean Supply Chain Management
• Problem Solving
• Process Control
• Process Engineering
• Process Oriented
• Product Improvements
• Science, Technology, Engineering, and Math (STEM) Application
• Situational Awareness
• Supply Planning
• Technical Research
• Technologically Savvy
• Validation Testing

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