Staff Process Development Engineer

1 day ago

Galway City, Ireland Careerwise Recruitment Full time

We are seeking an experienced Staff Process Development Engineer for our Galway based client by CareerWise Recruitment This critical role will focus on designing, developing, and optimizing manufacturing processes for innovative medical devices, ensuring compliance with industry regulations.
The role will further develop company methodologies to standardize and optimise steps for process characterisation, process development and industrialisation.
The ideal candidate will drive process improvements, lead technical projects, and act as a mentor to junior team members, contributing to the delivery of repeatable manufacturing process and in turn products at the highest quality and efficiency standards.
THE ROLE: Process Development Further development of a standard approach to process development.
Process and material benchmarking Evaluate and implement state-of-the-art technologies, materials, and methods to optimize manufacturing operations.
Achieved through: Benchmarking Research Network development vendor and education centres.
Scale up processes from pilot-scale to full-scale production, ensuring robustness and repeatability.
Directing teams internally and working with customers through the process.
Lead the development and validation of new manufacturing processes from concept to production.
Regulatory Compliance Develop and maintain process documentation in compliance with regulatory requirements.
Support regulatory submissions by providing process data, validation protocols, and technical reports.
Ensure all processes meet quality standards including risk management.
Cross-Functional Collaboration Partner with Prototyping, Quality, and Manufacturing teams to ensure seamless integration of new processes into production.
Act as a technical liaison with suppliers to ensure material and component quality align with process requirements.
Continuous Improvement Drive continuous improvement initiatives to enhance process efficiency, reduce costs, and improve product quality.
Apply Six Sigma, Lean Manufacturing, and other methodologies to optimize process performance.
Monitor and analyze production data to identify and address process variances.
Leadership & Mentorship Lead the optimisation and roll out of a lean process development system within the company.
Lead technical projects, including resource planning, timeline management, and risk assessment.
Mentor junior engineers and technicians, fostering a collaborative and innovative team environment.
Provide subject-matter expertise during audits and technical reviews.
Qualifications Bachelors degree in engineering (e.g., Mechanical, Biomedical, or related field).
8+ years of experience in process development in the medical device industry.
Demonstrated expertise in developing and scaling manufacturing processes for regulated environments.
Hands-on experience with process validation (IQ, OQ, PQ) and statistical process control (SPC).
Skills In-depth knowledge of medical device regulations and standards, including ISO 13485 and FDA cGMP.
Strong proficiency in data analysis tools and techniques (DOE, Minitab, etc.).
Expertise in manufacturing technologies such as injection moulding, laser processing, automation, or additive manufacturing.
Excellent project management skills with a proven ability to lead cross-functional teams.
Strong verbal and written communication skills, including technical documentation.
Preferred Certification in Lean Six Sigma (Green Belt, Black Belt) or equivalent.
Experience with Design for Manufacturability (DFM) and Design for Assembly (DFA).
Familiarity with cleanroom operations and sterilization processes (e.g., EtO, gamma).
Please call Tom Devaney today for further information on or email: CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.
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Skills: Staff Process Development Engineer Process Development Engineer Staff PDE

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