Senior NPI Engineer

Freudenberg Group; Spiddal; On-site; EUR 70,000 - 110,000; Full time

Benefits offered by this job

Flexible Work Models

Company Pension

Education Reimbursement

Personal Development

Job summary

Freudenberg Medical Ireland Ltd. is recruiting an engineer to join a regulated medical device manufacturing environment. The role focuses on developing, validating and transferring precision manufacturing processes, including laser welding and laser cutting, into high-volume production.

You will contribute to NPIs, support IQ/OQ/PQ activities and apply Lean Six Sigma tools to drive continuous improvement while ensuring compliance with ISO 13485 standards and robust technical documentation.

Qualifications

• 5+ years engineering experience in medical device or regulated manufacturing.
• Experience developing, optimising and transferring manufacturing processes to production.
• Experience supporting NPI programmes in ISO 13485 environment.
• Strong understanding of DOE, Gauge R&R, and process capability studies.

Skills

Problem-solving

Communication

Education

Level 8 degree or higher in Mechanical/Manufacturing/Mechatronics/Biomedical Engineering

Tools

Laser welding

Laser cutting

DOE

Gauge R&R

Process validation IQ/OQ/PQ

Lean Six Sigma

Job description

Working at Freudenberg: \"We will wow your world!\" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.
Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high-quality solutions from ideation and market launch to volume production for medical device and pharmaceutical companies. With proven expertise in materials and technologies, Freudenberg Medical offers an extensive range of vertically integrated capabilities: precision molding and extrusions, complex catheters, hypotubes, and coatings.

Some of your Benefits

Flexible Work Models: We allow for flexible work models to ensure both professional and personal success.

Company Pension

Company Pension: Save for retirement with the company's help.

Education Reimbursement

Education Reimbursement: Receive financial aid to help propel your career to the next level.

Personal Development

Personal Development: We offer a variety of trainings to ensure you can develop in your career.

On-Site

trip_origin Freudenberg Medical Ireland Ltd.

Join our team as a:

Qualifications

• Level 8 degree or higher in Mechanical, Manufacturing, Mechatronics, Biomedical Engineering or a related technical discipline.
• Ideally a minimum of 5 years engineering experience within a medical device, pharmaceutical or similarly regulated manufacturing environment.
• Strong technical expertise in laser welding, laser cutting or other precision manufacturing technologies.
• Proven experience developing, optimising and transferring manufacturing processes into commercial production.
• Experience supporting NPI programmes, ideally within an ISO 13485-regulated environment.
• Strong understanding of process validation methodologies, including IQ, OQ, PQ and associated technical documentation.
• Experience applying statistical analysis tools such as DOE, Gauge R&R and process capability studies.
• Knowledge of Lean Six Sigma, continuous improvement or structured project management methodologies would be advantageous.
• Excellent problem-solving skills, with the ability to analyse complex technical challenges and develop practical solutions.
• Strong communication and interpersonal skills, with the confidence to lead technical discussions, influence stakeholders and collaborate across teams.

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.