Lead Process Validation Engineer for MedTech Scale-Up

UroMems company; Fontanil-Cornillon; On-site; EUR 70,000 - 95,000; Full time

Benefits offered by this job

CDI contract

Competitive salary and package

International environment

Job summary

UroMems is a pioneering MedTech company developing implantable technologies for urological disorders. We seek a Process Validation Lead Engineer to define and drive the validation strategy for internal manufacturing and supplier processes, ensuring quality and patient safety as we scale production.

You will lead IQ/OQ/PQ activities, develop validation documentation, and manage a team of validation professionals, partnering with Quality, Industrialization, and Supply Chain to ensure regulatory

Qualifications

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

Responsibilities

• Lead and maintain the Validation Master Plan and validation roadmap.
• Establish validation methodologies, 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.
• 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.
• 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.
• 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.
• 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.

Education

Engineering degree in Mechanical Engineering

Industrial Engineering

Process Engineering

Quality Engineering

Materials Science

Certifications in process validation

Six Sigma

Quality management

Risk management

Project management

Job description

UroMems is a pioneering MedTech company developing implantable technologies for urological disorders. We seek a Process Validation Lead Engineer to define and drive the validation strategy for internal manufacturing and supplier processes, ensuring quality and patient safety as we scale production.

You will lead IQ/OQ/PQ activities, develop validation documentation, and manage a team of validation professionals, partnering with Quality, Industrialization, and Supply Chain to ensure regulatory