Senior Process Development Engineer

Freudenberg; Galway; Hybride; EUR 80 000 - 110 000; Plein temps

Résumé du poste

Freudenberg Medical Ireland Ltd. seeks a Senior Process Development Engineer to lead end-to-end development and productionization of manufacturing processes.

You will apply expertise in process methods and collaborate across functions to drive NPI programs while ensuring ISO 13485 compliance and robust validation activities. The role requires strong communication, leadership, and project management skills, with a focus on continuous improvement and energy-efficient practices in a medical device

Qualifications

• NFQ Level 8 or higher in a technical discipline (Mechanical, Manufacturing, Mechatronics or Biomedical) preferred.
• Highly effective communication with ability to liaise across levels of the organization.
• Lean Six Sigma, Agile Project Management, or similar methodologies advantageous.

Responsabilités

• Lead end-to-end development and productionization of manufacturing processes.
• Collaborate with cross-functional teams to execute NPI programs ensuring ISO 13485 compliance.
• Lead Process Validation for final release of products into manufacturing.

Connaissances

Communication

Cross-functional collaboration

Leadership

Formation

NFQ Level 8+ in a technical discipline

Outils

PMBOK

Agile

Lean Six Sigma

Description du poste

## Senior Process Development EngineerApply: Spiddal, Co. Galway: Full time: Posted Today: R\\_00108158**Working at Freudenberg: We will wow your world!**# Responsibilities:Lead the end-to-end development and productionization of pull band manufacturing processes.Apply expertise in laser welding and laser cutting to develop robust, scalable, and cost-effective manufacturing solutions.Collaborate with cross-functional teams in the execution of New Product Introduction (NPI) programs ensuring compliance with ISO 13485.Develop and maintain Product Technical Files, including risk assessments and supporting validation studies.Utilize statistical tools (e.g., R&R studies, DOE, equivalence tests) to optimize and validate processes.Lead Process Validation for final release of products into commercial manufacturing.Ensure strict compliance with quality, regulatory, and business requirements during all project stages.Use project management methodologies (e.g., PMBOK, Agile) to drive timely and effective project execution.Provide technical leadership and mentoring to junior engineers and support staff.Stay informed of market trends, competitive technologies, and industry best practices to maintain a high-performing process development function.Contribute to enhanced energy performance by conservation of energy where possible (Lighting, Equipment, Air Conditioning etc).Contribute to the continual improvement activities of the OH&S, Environmental and Energy Management systems through participation, providing feedback/ suggestions for improvement and by reporting accidents, dangerous occurrence, near miss/ illness, good catch and environmental incidents in a timely manner.To take on other duties which the Company may assign you from time to time. These ‘other duties’ will be agreed with Management prior to any assignment.# Qualifications:NFQ Level 8 or higher in a Technical Discipline (Mechanical, Manufacturing, Mechatronics or Bio-Medical) is preferred.Ideally 5-7 years previous experience working within Medical Device/ Pharma Environment.Highly effective and articulate communication skills with an ability to convey and link with people at all levels of the organisation.An ability to work cross functionally as this role requires interaction with different functions across the Group.Demonstrates a behaviour of high performance and creates an environment of high engagement within the NPI team.Certification or training in Lean Six Sigma, Agile Project Management, or similar methodologies.Good communication and interpersonal skills. 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.Freudenberg Medical Ireland Ltd.