Principal Process Development Engineer

Principal Process Development Engineer required in Galway – An innovative medical technology start-up, is seeking a Principal Process Development Engineer to join their growing team. The company is at the forefront of developing cutting-edge medical technologies designed to solve global healthcare challenges. If you are passionate about advancing medical technologies and have extensive experience in process development and manufacturing, this opportunity may be a perfect fit.

As a Principal Process Development Engineer, you will be responsible for leading process development and manufacturing engineering activities, with a focus on collaborating with external suppliers in Galway. The role requires a blend of technical leadership, project management and a commitment to continuous improvement. You’ll drive projects that enhance manufacturing performance, streamline production and ensure compliance with industry standards.

REQUIREMENTS:

• Bachelor’s Degree in Engineering or a related discipline

• Minimum of 7 years’ experience in process development and manufacturing, with at least 3 years in a leadership role within the biotechnology, pharmaceutical, or medical device industries

• Expertise in working within ISO 13485/FDA-regulated quality systems and applying risk management methodologies

• Proven track record in manufacturing process development and a deep understanding of DFM, technology evaluation, materials (polymers and metals) and design for six sigma principles

• Experience in CAD (preferably SolidWorks) and applying statistical techniques for process design and validation

• Strong project management experience with a demonstrated ability to lead cross-functional teams and deliver projects on time

• Ability to thrive in a high-growth, fast-paced environment, managing multiple tasks efficiently

• Strong analytical, decision-making, negotiation and leadership skills

RESPONSIBILITIES:

• Lead the manufacturing transfer of new products and changes to existing products, leveraging Design for Manufacturability concepts

• Develop and implement LEAN manufacturing capabilities, including tools such as Value Stream Mapping, Poka-Yoke, Standard Work, and Bottleneck Analysis

• Manage NCMRs, CAPAs, supplier monitoring, audits, and risk management to ensure compliance with ISO 13485 and other relevant regulations

• Collaborate with cross-functional teams and stakeholders to achieve production performance goals

• Contribute to the execution of departmental and company objectives, aligning with cross-functional business targets

• Oversee the development and execution of manufacturing timelines that align with project and regulatory requirements

• Lead technology transfer to contract manufacturing organizations and ensure scalability of production capacity

• Support a continuous improvement culture and spearhead cost-saving initiatives

• Develop and manage the annual budget for manufacturing projects

• Provide strategic direction, technical expertise, and leadership to the organization