Lead Research and Development Engineer
Location: Limerick, Ireland

Overview: The Lead Research and Development Engineer will oversee a team of engineers dedicated to the research, development, and implementation of innovative medical device designs. This role provides technical leadership within project teams, including approving deliverables, mentoring team members, and delegating responsibilities effectively.

Reports to: Manager/Senior Manager, Research and Development

Key Responsibilities:

Project Leadership:

• Lead medium to large-scale R&D projects, providing technical expertise across multiple projects or specialized areas.
• Develop and optimize chemical and physical analytical methods to support early-stage product development.
• Drive capacity analysis within the Pharmaceutical Development Formulation team to ensure efficient resource and equipment utilization.

Technical Excellence:

• Collaborate with internal and external teams to identify and evaluate Critical Material Attributes (CMAs).
• Champion improvement initiatives, including ownership of departmental processes.
• Incorporate lean principles into the design and implementation of new processes where applicable.

Project Management:

• Approve project deliverables and oversee work outputs to meet timelines and quality standards.
• Drive project milestones and ensure alignment with business objectives in collaboration with project managers.
• Foster effective relationships with cross-functional teams to achieve project and company goals.

Design Leadership:

• Lead technical development efforts and key design decisions to ensure high-quality solutions meet customer needs.
• Conduct retrospective reviews of projects to identify lessons learned for future initiatives.
• Oversee device evaluations, ensuring compliance with quality and regulatory standards, as well as internal policies.

Compliance and Industry Engagement:

• Ensure all work complies with guidance and best practices, such as USP, Ph. Eur., and ICH.
• Represent the company in industry standards committees, working groups, and conferences. Mentorship:
• Act as a mentor to department personnel, fostering their technical and professional growth.
• Support training initiatives to strengthen team capabilities.

Qualifications and Experience:

• Bachelor’s degree in Engineering (preferably Polymer Science, Industrial Chemistry, or Pharmaceuticals) or a related field, with 7+ years of relevant experience, OR
• Master’s degree with 5+ years of relevant experience, OR
• PhD with 4+ years of relevant experience.
• Extensive experience in product development for medical devices, including combination product development.
• Deep understanding of technologies and challenges related to formulation and product development.
• Competence in chemical and physical analytical methodologies and testing procedures for formulation approval.
• Proven knowledge of technical transfer processes to manufacturing operations.

Leadership Skills:

• Demonstrated technical and project leadership experience.
• Strong project management skills, with experience collaborating closely with project managers.
• In-depth knowledge of ISO, EU, and FDA medical device standards and regulations.