Senior Process Development Engineer About Your New Company: Based in Galway, this growing SME, is seeking an experienced Senior Process Development Engineer with medical device experience to join their team.
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.
About Your New Job as a Senior Process Development Engineer: Evaluate and implement state-of-the-art technologies, materials, and methods to optimize manufacturing operations.Scale up processes from pilot-scale to full-scale production, ensuring robustness and repeatability.Direct teams internally and working with customers through the processLead the development and validation of new manufacturing processes from concept to production.Partner with Prototyping, Quality, and Manufacturing teams to ensure seamless integration of new processes into production.Apply Six Sigma, Lean Manufacturing, and other methodologies to optimize process performance.Lead technical projects, including resource planning, timeline management, and risk assessment.What Skills You Need: Bachelor's degree in engineering (e.g., Mechanical, Biomedical, or related field).6+ 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).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).Benefits Competitive salary and performance-based bonus.Healthcare to include dependants from day 1.Occupational Pension Scheme.Additional Annual LeaveOpportunities for professional growth and development.What's Next? Click 'Apply Now' or for more information, please contact ******.
#J-18808-Ljbffr