Senior Process Development Engineer

Freudenberg Medical, LLC; Spiddal; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Health Insurance

Flexible Work Models

Company Pension

Education Reimbursement

Personal Development

Job summary

Freudenberg Medical Ireland Ltd. is seeking a Senior Process Development Engineer to join our growing team.

You will own the development, optimisation and productionisation of advanced manufacturing processes, focusing on laser welding and laser cutting to move products from development to commercial manufacturing. You will lead process validation, drive continuous improvement, mentor junior engineers and collaborate across Engineering, Quality and Operations to ensure compliant, scalable

Qualifications

• Bachelor's degree or higher in Mechanical/Manufacturing/Mechatronics or related technical discipline.
• 5+ years engineering experience in medical device/pharma or regulated manufacturing.
• Strong technical expertise in laser welding, laser cutting or similar precision manufacturing.
• Experience developing, optimising and transferring processes to commercial production.

Responsibilities

• Lead development, optimisation and productionisation of advanced manufacturing processes (laser welding, laser cutting, pull band).
• Own process development from concept through validation to full-scale production.
• Contribute to NPI programmes with cross-functional teams (Engineering, Quality, Operations).
• Develop robust, scalable, cost-effective manufacturing solutions meeting quality and regulatory requirements.
• Plan and execute IQ/OQ/PQ validation activities and maintain technical documentation.

Skills

Laser welding

Laser cutting

Pull band manufacturing

Education

Mechanical Engineering degree (Level 8+)

Tools

Advanced manufacturing technologies

Laser-based processes

ISO 13485 knowledge

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

• 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 Process Development Engineer

Responsibilities

• Join our growing team at Freudenberg Medical as a Senior Process Development 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.