Medical Device Company jobs in Spiddal, County Galway

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.

Join our team as a:

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.

Some of your Benefits

Health Insurance

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.

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.