Senior Process Validation Lead for MedTech Scale-Up

UroMems company; Auvergne-Rhône-Alpes; On-site; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Competitive salary

International environment

Job summary

UroMems is a pioneering MedTech company advancing implantable technologies for urological care. We are hiring a Process Validation Lead Engineer to shape and drive the validation strategy across internal manufacturing and external suppliers, ensuring ISO 13485 compliance and patient safety.

You will lead validation activities from planning through execution, align product quality with manufacturing performance, and support ramp-up and industrialization while collaborating with Supply Chain,

Qualifications

• 7+ years in Process Validation or related roles in regulated industry.
• Strong experience with IQ/OQ/PQ and validation programs.
• Experience with medical devices ISO 13485 environments.
• Experience collaborating with suppliers and contract manufacturers.
• Previous team lead or management experience is highly desirable.

Responsibilities

• Define and maintain Validation Master Plan and roadmap.
• Lead IQ, OQ, PQ, validation activities and revalidation.
• Develop and review validation protocols, reports, deviations, investigations, and conclusions.
• Coordinate validation with suppliers and manufacturing partners.
• Support industrialization, ramp-up, risk mitigation, and regulatory inspections.

Skills

Process validation

IQ/OQ/PQ

Regulatory compliance

Cross-functional leadership

Project management

Education

Mechanical/Industrial Engineering degree

Six Sigma / quality management certs

Job description

UroMems is a pioneering MedTech company advancing implantable technologies for urological care. We are hiring a Process Validation Lead Engineer to shape and drive the validation strategy across internal manufacturing and external suppliers, ensuring ISO 13485 compliance and patient safety.

You will lead validation activities from planning through execution, align product quality with manufacturing performance, and support ramp-up and industrialization while collaborating with Supply Chain,