Principal Process Development Engineer

3 days ago


Galway, Ireland Life Science Recruitment Ltd Full time

Our client a medical device start-up who developing cutting edge innovative device to significantly advance healthcare are currently looking for a Principal Process Development Engineer to join their growing team to work. This role will be responsible for leading Process Development and Manufacturing Engineering activities. The role is hybrid and will work in close conjunction with Galway based supplier and successful candidate will be required to work on-site with supplier in Galway 3 days per week. Role/Responsibility: Technical leadership of the manufacturing transfer of new products and changes to existing products, supporting the successful transition to manufacturing using design for manufacturability concepts, as applicable. Develop and Implement manufacturing capabilities using LEAN principles and tools including but not limited to Value Stream Mapping, Poka-Yoke, Standard Work, Bottleneck Analysis and Line Balance Responsible for working with Quality including management of NCMRs and CAPAs, supplier monitoring and audits, risk management and internal controls while ensuring compliance with ISO 13485 and other relevant standards and regulations pertaining to medical device and pharmaceutical products. Contribute to the successful execution of departmental and company goals. Regularly update and recommend to stakeholders the status of objectives, projects, and goals, particularly how they relate to cross-functional business objectives. Support business partners by providing technical leadership for companys long-term manufacturing and distribution channels. Development and execution of commercial manufacturing timelines consistent with project and regulatory needs; Financial modeling for COGS and scaling up production capacity. Technology transfer to partner or contract manufacturing organizations, as applicable Promote and support a continuous improvement culture and drives cost saving initiatives. Create and manage annual budget for Manufacturing project activities. Provide strong integrity, vision, knowledge, and overall aptitude to the organization. Skills/Experience: Bachelors degree in engineering or related specialty with a minimum of 7 years experience with at least 3 years in a technical leadership role in a biotechnology, pharmaceutical or medical device industry. Experienced in working within ISO 13485/FDA regulated quality systems with understanding and application of risk management methodology A proven track record in manufacturing and process development in a regulated environment. Medical device catheter product experience a plus. Ability to achieve results in a virtual organisation. Experience working with cross-functional teams, project facilitation and demonstrated ability to complete projects on time. This role is primarily technical in nature; thus, we seek someone who is passionate about Engineering concepts and principles - someone who gets a thrill from how and why things work A seasoned professional in manufacturing & engineering development with knowledge and skills in some or all of the following: DFM, technology evaluation, driving innovative solutions to complex problems, process design and development, materials (polymers and metals), design for six sigma principles, CAD (SolidWorks preferred), statistical techniques, process validation and control along with Manufacturing KPIs Excellent analytical and decision-making skills Possess a flexible, pro-active approach to problem solving, be an adept negotiator and apply risk-based decisions Strong organizational, communication, interpersonal, managerial and leadership skills Ability to effectively and efficiently manage consultants, suppliers, vendors and budgets. Ability to work in a fast paced, high growth environment. Ability to handle multiple tasks with high quality to meet Business timelines. For further information please contact James Cassidy or call in confidence Skills: Process Development NPI Development Engineer



  • Galway, Ireland Life Science Recruitment Full time

    Principal Process Development Engineer Our client, an established and high potential startup medical device company, is currently seeking a Principal Process Development Engineer to join their team. Reporting to the CTO, the Principal Process Development Engineer will hold a key role within the R&D team and work in collaboration with Operations, Quality,...


  • Galway, Ireland CareerWise Recruitment Full time

    A Principal Process Development Engineer is required by CareerWise Recruitment for our Galway based client. 3 days per week in the office, 2 days remote!! The Principal Process Development & Manufacturing Engineer is responsible for leading Process Development & Manufacturing Engineering activities, including activities at contract manufacturing suppliers...


  • Galway, Ireland CareerWise Recruitment Full time

    A Principal Process Development Engineer is required by CareerWise Recruitment for our Galway based client. 3 days per week in the office, 2 days remote!! The Principal Process Development & Manufacturing Engineer is responsible for leading Process Development & Manufacturing Engineering activities, including activities at contract manufacturing suppliers...


  • Galway, Ireland Life Science Recruitment Full time

    Senior/Principal R&D Engineer, Catheter Development Our client a Medical Device company who have recently established a base in Ireland are currently seeking a Senior or Principal Level R&D Engineer to join their team to work on Catheter Development. Reporting to VP of R&D the Senior/Principal R&D Engineer, Catheter Development, will be an experienced...


  • Galway, Ireland Reperio Human Capital (Ireland) Ltd Full time

    Principal Software Engineer Limerick/Galway Hybrid My client in the Consulting space is looking for a seasoned Principal Software Engineer with expertise in Java, AWS technologies, Spring/Springboot, Docker, Kubernetes, Jenkins, and Node.js. You will also have solid exposure on front-end technologies like Angular or React and will be responsible for the...


  • Galway, Ireland Life Science Recruitment Ltd Full time

    Principal Quality Engineer Our client a high potential and well-funded startup company are seeking a Principal Quality Engineer to join their team. Reporting to the VP of Quality and Regulatory Affairs. The Principal Quality Engineer will work as part of the Quality and Regulatory Affairs teams and be responsible for tasks that are related to the development...


  • Galway, Ireland Life Science Recruitment Ltd Full time

    Principal Quality Engineer Our client a high potential and well-funded startup company are seeking a Principal Quality Engineer to join their team. Reporting to the VP of Quality and Regulatory Affairs. The Principal Quality Engineer will work as part of the Quality and Regulatory Affairs teams and be responsible for tasks that are related to the development...


  • Galway, Ireland Reperio Human Capital (Ireland) Ltd Full time

    Principal Software Engineer Limerick/Galway Hybrid My client in the Consulting space is looking for a seasoned Principal Software Engineer with expertise in Java, AWS technologies, Spring/Springboot, Docker, Kubernetes, Jenkins, and Node.js. You will also have solid exposure on front-end technologies like Angular or React and will be responsible for the...


  • Galway, Ireland Real Full time

    Title: Join Our Team as a Process Development Engineer in Galway!Introductory Paragraph:Our esteemed client, a leader in the Medical Devices sector is seeking an experienced and highly motivated individual to fill the role of Process Development Engineer. The successful candidate will be responsible for developing new processes that improve production...


  • Galway, Ireland Merit Medical Ireland Ltd Full time

    Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world. SUMMARY OF DUTIES This exciting opportunity is a key...


  • Galway, Ireland Real Full time

    A global medical device company are looking for a Process Development Engineer to join their Process Development team on a contract basis. You will assist the team leads with new versions of an existing product and one next generation product. We are looking for someone with a can do attitude that is happy to get stuck in and involved with whatever the...


  • Galway, Ireland Ministry Brands Full time

    Principal Developer – e Commerce We are looking for an experienced Principal Developer to join our R&D development centre in Ireland. Our team in Ireland is focused on building the next-generation cloud-native Saa S platform aimed at purpose-driven organisations, leveraging new technology to bring innovative products to market. What you will do: This is a...


  • Galway, 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...


  • Galway, Ireland Stem Recruitment Partners Full time

    Staff Process Development Engineer - Galway- Permanent role. Our client in Galway is seeking an experienced Staff Process Development Engineer to join their team. The ideal candidate will have experience working with Catheters, be available for a full-time onsite role, have an existing work permit/ visa for Ireland(Stamp 4 or EU passport) reside within a...


  • Galway, Ireland Trust In SODA Full time

    Principal Site Reliability Engineer (BH-112856) Location: Galway, Ireland Sector: IT Salary: 95,000.00 EU to 100,000.00 EU per annum Benefits: Bonus, Pension, Healthcare One of our long-term Galway-based clients in the financial services space is expanding and they're looking for a Principal Site Reliability Engineer to join the team. They have been...


  • Galway, Ireland CareerWise Recruitment Full time

    A Senior Product Development Engineer is required by CareerWise Recruitment for our multinational medical device client in Galway for a fulltime on-site role on an initial 12-month contract. The Senior Product Development Engineer will design manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing,...


  • Galway, Ireland Adecco Ireland Full time

    We have Principal and Senior level contract roles in Galway (12 months) for experienced Genesys Engineers! Our client is seeking a talented individual to join their team and contribute to their Contact Centre platform and engineering. This is great opportunity to be at the beginning of new team set up! You will lead technology solutions to deliver business...


  • Galway, Ireland Trust In SODA Full time

    Principal Systems Engineer Another exciting new role just gone live in Galway! Working in partnership with our Financial Services client who are continuing to expand and looking for a talented systems engineer from the Voice sector. Ideally, they're looking for an experienced senior or lead engineer coming from a Telco or contact centre background. You'll...


  • Galway, Ireland Adecco Ireland Full time

    New Contract: Principal / Senior Performance Engineer Great Contract 12 months role with great benefits in Galway - hybrid working model - one week per month! Ideal candidate will have a proven knowledge on a number of testing skills, be detail oriented and will work closely with the development team. Job Role: You will be responsible for providing...


  • Galway, Ireland CVS Health Ireland Full time

    CVS Health, the parent company of Signify Health, is increasing investments in digital, data, analytics and technology and Signify Health is excited to be involved! We are hiring for a dynamic new initiative for CVS Health that will run out of our state-of-the-art offices at Bonham Quay. This is your opportunity to be involved with a pioneering business that...