Senior Medical Device Process Development Engineer

Freudenberg Group; Spiddal; On-site; EUR 70,000 - 95,000; Full time

Job summary

Freudenberg Group Ireland seeks an experienced process development engineer to lead end-to-end development and productionization of pull band manufacturing processes. You will apply laser welding and laser cutting to build robust, scalable solutions.

You will drive New Product Introduction programs, ensure ISO 13485 compliance, and develop Product Technical Files including risk assessments and validation studies.

Qualifications

• NFQ Level 8 or higher in a Technical Discipline (Mechanical, Manufacturing, Mechatronics or Bio-Medical) preferred.
• 5-7 years of experience in Medical Device/Pharma environments would be ideal.
• Strong communication skills with the ability to engage at all levels of the organisation.
• Ability to work cross-functionally across different groups within the Freudenberg Group.
• Demonstrates high performance and drives engagement within the NPI team.
• Certification or training in Lean Six Sigma, Agile Project Management, or similar methodologies.

Responsibilities

• Lead end-to-end development and productionization of pull band manufacturing processes.
• Apply laser welding and laser cutting expertise to create robust, scalable solutions.
• Collaborate with cross-functional teams on New Product Introduction programs ensuring ISO 13485 compliance.
• Develop and maintain Product Technical Files, including risk assessments and validation studies.
• Use statistical tools (R&R, DOE, equivalence tests) to optimize and validate processes.
• Lead Process Validation for final product release into manufacturing.
• Ensure compliance with quality, regulatory, and business requirements throughout projects.
• Provide technical leadership and mentoring to junior engineers and support staff.

Skills

Communication

Cross-functional work

Project leadership

High performance mindset

Lean Six Sigma

Agile Project Management

Education

Technical degree (Mechanical/Manufacturing/Mechatronics/Bio-Medical)

Job description

Freudenberg Group Ireland seeks an experienced process development engineer to lead end-to-end development and productionization of pull band manufacturing processes. You will apply laser welding and laser cutting to build robust, scalable solutions.

You will drive New Product Introduction programs, ensure ISO 13485 compliance, and develop Product Technical Files including risk assessments and validation studies.