Senior NPI Engineer

Freudenberg Medical, LLC; Spiddal; On-site; EUR 65,000 - 85,000; Full time

Benefits offered by this job

Health Insurance

Flexible Work Models

Company Pension

Education Reimbursement

Personal Development

Job summary

Freudenberg Medical Ireland Ltd. in Spiddal, Co. Galway, is seeking a Senior NPI Engineer to lead new product introductions with advanced laser technologies, taking ownership from concept through to production.

You will drive process development, validation, and optimisation while collaborating with Engineering, Quality and Operations across cross-functional teams. A Level 8 degree and 5+ years in medical device manufacturing are preferred; Lean Six Sigma or CI knowledge is advantageous.

Qualifications

• Level 8 degree or higher in Mechanical/Manufacturing/Mechatronics or related field.
• 5+ years engineering experience in medical device or regulated manufacturing.
• Experience with laser welding or laser cutting.
• Experience transferring manufacturing processes to production; ISO 13485 exposure.
• Strong analytical and problem-solving skills; good communication.

Responsibilities

• Lead NPI projects from development to commercial manufacturing.
• Develop and optimize laser-based manufacturing processes.
• Own process validation activities (IQ/OQ/PQ).
• Maintain technical documentation and risk assessments.
• Provide technical leadership and mentorship to engineers.

Skills

Laser welding

Laser cutting

DOE / Gauge R&R / Process capability

Lean Six Sigma / CI methods

Education

Level 8 degree or higher in Mechanical, Manufacturing, Mechatronics, Biomedical Engineering or related field

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.

Benefits

• Health Insurance: Rely on comprehensive services whenever you need it.
• Flexible Work Models: We allow for flexible work models to ensure both professional and personal success.
• Company Pension: Save for retirement with the company's help.
• Education Reimbursement: Receive financial aid to help propel your career to the next level.
• Personal Development: We offer a variety of trainings to ensure you can develop in your career.

Spiddal, Co. Galway

On-Site

Freudenberg Medical Ireland Ltd.

Senior NPI Engineer

Responsibilities

• Join our growing team at Freudenberg Medical as a Senior NPI Engineer, with the opportunity to work with advanced laser technologies, take ownership of technically challenging projects and bring innovative medical device products from development through to commercial manufacturing.
• Lead the development, optimisation and productionisation of advanced manufacturing processes, with a particular focus on laser welding, laser cutting and pull band manufacturing.
• Take ownership of process development activities from initial concept through to validation and full-scale commercial production.
• Play a key role in New Product Introduction (NPI) programmes, collaborating with Engineering, Quality, Operations and other cross-functional teams.
• Develop robust, scalable and cost-effective manufacturing solutions that meet product, quality and regulatory requirements.
• Plan and execute process validation activities, including IQ, OQ and PQ, to support successful product launches.
• Apply statistical techniques, including Design of Experiments (DOE), Gauge R&R and equivalence testing, to optimise process performance and reliability.
• Develop and maintain technical documentation, including Product Technical Files, risk assessments, validation protocols and reports.
• Drive continuous improvement initiatives to enhance manufacturing efficiency, product quality and process capability.
• Provide technical leadership and mentorship to junior engineers while managing project timelines and deliverables to ensure successful NPI execution.

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.