Process Validation Lead Engineer

UroMems is a pioneering MedTech company developing innovative implantable technologies that transform the treatment of urological disorders.

As we move toward industrialization and scale-up, we are looking for a Process Validation Lead Engineer to lead our validation strategy and ensure manufacturing processes consistently deliver the highest standards of quality, compliance, and patient safety.

Your Mission

As Process Validation Lead Engineer , you will define and execute the process validation strategy for UroMems' internal manufacturing operations and external suppliers.

You will ensure that manufacturing and special processes are validated, monitored, and maintained in compliance with ISO 13485 and regulatory expectations, while supporting the company's production ramp-up and operational readiness.

You will lead validation activities from planning through execution and continuous monitoring, ensuring alignment between product quality, manufacturing performance, supplier maturity, and business objectives.

What You Will Do

Lead Process Validation Strategy

• Define and maintain the company's Validation Master Plan and validation roadmap.
• Establish validation methodologies, standards, templates, and acceptance criteria.
• Ensure critical manufacturing and outsourced processes are appropriately validated, revalidated, or scientifically justified.
• Prioritize validation activities according to business needs, product risks, and regulatory milestones.

Drive Validation Execution

• Lead and coordinate IQ, OQ, PQ, process characterization, and revalidation activities.
• Develop and review validation protocols, reports, deviations, investigations, and final conclusions.
• Ensure complete traceability between design requirements, process risks, validation evidence, and release criteria.
• Support root cause investigations and corrective actions related to validation findings.

Collaborate with Suppliers and Manufacturing Partners

• Coordinate validation activities at suppliers and subcontractors.
• Assess supplier readiness, process capability, and industrial maturity.
• Review validation documentation and ensure compliance with UroMems quality expectations.
• Partner with Supply Chain, Quality, and Industrialization teams to resolve process-related issues and validation gaps.

Support Industrialization and Ramp-Up

• Integrate validation activities into production scale-up plans.
• Evaluate validation impacts related to process transfers, equipment changes, tooling, and supplier modifications.
• Identify risks affecting manufacturing readiness and implement mitigation plans.
• Support audit readiness and regulatory inspections through inspection-ready documentation.

Lead the Team

• Manage, coach, and develop a team of validation professionals.
• Set objectives, allocate priorities, and monitor project execution.
• Foster technical excellence, accountability, and continuous improvement.
• Contribute to recruitment, onboarding, and competency development initiatives.

What You Bring

Education

• Engineering degree in Mechanical Engineering, Industrial Engineering, Process Engineering, Quality Engineering, Materials Science, or a related technical discipline.
• Additional certifications in process validation, Six Sigma, quality management, risk management, or project management are a plus.

Experience

• 7+ years of experience in Process Validation, Manufacturing Engineering, Supplier Quality, Industrialization, or Quality Engineering within a regulated industry.
• Strong experience in medical devices and ISO 13485 environments.
• Proven experience planning and executing IQ/OQ/PQ activities and validation programs.
• Experience working with suppliers and contract manufacturers.
• Previous team lead or management experience is highly desirable.
• Experience supporting product industrialization, design transfer, CAPA, change control, and manufacturing scale-up.

What we propose:

• CDI contract
• Competitive salary and package
• International environment

All our positions are open to people with disabilities, provided they have the required skills.