Senior Project Engineer

Job title: Senior Project Engineer

Company: Morgan McKinley


Job description: Seeking a highly experienced Senior Project Engineer to lead and support complex New Product Development (NPD) and process development initiatives in collaboration with R&D and Manufacturing teams. This role will be instrumental in developing and implementing robust, scalable manufacturing processes and supporting the full lifecycle of medical device products – from concept and design through to commercialization.Key ResponsibilitiesServe as the technical lead on NPD projects, partnering with R&D to ensure new designs are manufacturable and scalable for production.Lead the development of robust, high-yielding manufacturing processes for new products in alignment with quality and regulatory standards.Drive design for manufacturability (DFM) activities, providing proactive input into product design to optimize for efficient production.Collaborate cross-functionally to plan, execute, and deliver process development activities in line with NPI timelines and quality targets.Engage with equipment vendors for custom automation and tooling solutions, managing these from concept through to onsite implementation.Author and execute IQ/OQ/PQ protocols for new processes and equipment associated with NPD programs.Ensure smooth transfer of validated manufacturing processes to the production floor, including operator training and documentation support.Identify and implement continuous improvements to support product quality, efficiency, and cost reduction.Lead cross-functional technical discussions and act as an SME in process development and NPD engineering strategy.Qualifications & ExperienceBachelor’s degree (Level 8) in Engineering or a related technical discipline (e.g., Mechanical, Manufacturing, Production, Electronic).8-10 years of experience in process or manufacturing engineering within the medical device industry, with a strong focus on new product development (NPD).Demonstrated leadership in end-to-end NPD projects, from concept through process validation and production ramp-up.Strong track record in process development, validation, and equipment qualification.Experience working in cross-functional teams with R&D, QA/RA, and Operations.Excellent problem-solving and analytical skills, with proven application of tools such as DOE, DMAIC, or Six Sigma.Skilled communicator with the ability to influence and lead technical teams and external partners.Hands-on experience in at least one of the following areas is required:Injection MouldingProcess CharacterizationEquipment ValidationDesign for Manufacturability (DFM)NPI/NPD in regulated manufacturing environments

Expected salary:

Location: Cork

Job date: Sat, 26 Apr 2025 02:03:24 GMT

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