Research and Development Lead

HERO Recruitment; Limerick; On-site; EUR 90,000 - 130,000; Full time

Job summary

HERO Recruitment seeks a Lead Research and Development Engineer to provide technical leadership in a cross-functional team, guiding the design and execution of stability studies and drug-device combinations to meet clinical needs and quality standards.

You will lead medium to large programs, collaborate with senior leadership, mentor staff, and ensure compliance with ISO, EU, and FDA medical device standards, while advancing new products and processes.

Qualifications

• Bachelor’s degree in Engineering with 7 years of relevant experience.
• Experience in Medical Device or regulated industries is preferred.
• Proven leadership of projects and teams with senior stakeholders.

Responsibilities

• Lead medium to large projects and support other teams as needed.
• Guide technical direction across multiple projects and mentors.
• Collaborate with senior leadership to identify focus areas and best practices.

Skills

Analytical thinking

Technical writing

Cross-functional leadership

AI/data concepts

Regulatory knowledge

Project management

Mentoring

Education

Bachelor's degree in Engineering

Job description

The Lead Research and Development Engineer will be a technical leader and/or growing subject matter expert, applying engineering principles to solve complex technical challenges and ensuring products meet clinical needs, safety requirements, and quality standards.

Leading a team in the development of drug-device combination products with a focus on the drug side. They should have working knowledge of designing and executing stability establishing studies in accordance with ICH guidelines and working knowledge of the analytical test methods required for characterisation of APIs.

In this role, they may have the following responsibilities:

• Lead medium to large projects/programs while also supporting other project teams, as needed.
• Collaborate across functional department(s), grow and advance their area of technical expertise, and provide guidance and technical leadership across multiple projects within their area.
• Work with senior leadership to identify focus area(s) for research and best practices.

It would be an advantage if the candidate also has working knowledge of the following areas:

• Polymer characterisation techniques
• Pre-filled syringe combination product design requirements
• Sustained release or hydrogel based formulation design
• Embolization product design
• Development of the formulation for a drug product
• Completion of CMC (chemistry manufacturing controls) development of that product.
• Execution of stability testing of the drug product.
• Successful market approval for the drug product through interactions with relevant regulatory agencies (e.g. FDA).
• Continue to perform the functions, duties, and expectations of the Senior Research and Development Engineer at a high level, as applicable.

Education and/or Work Experience

• Bachelor’s degree in Engineering and 7 years’ relevant experience. Relevant advanced degrees (Master’s or PhD) may reduce the experience requirement by 2-4 years.
• Experience in a technical role within Medical Device or regulated industry/adjacent experience.
• Project/technical leadership experience.
• Experience working closely with senior leadership.
• Experience in successfully mentoring, guiding, and training employees within an area of expertise is preferred.

Knowledge and Skills and/or Abilities

• Strong analytical and critical thinking skills.
• Strong technical writing.
• Proven ability to work with cross functional teams to solve complex problems.
• Proven ability to develop and lead elements of new products and processes in achieving functional objectives.
• Knowledge of relevant ISO, EU, FDA medical devices standards regulations.
• Strong influencing skills required to secure support/buy-in across the function, driving acceptance and understanding of new concepts and/or approaches.
• Project management methodology and skills is preferred.
• This role requires fluency in Artificial Intelligence (AI) and data concepts, including the ability to critically evaluate AI outputs, improve workflows using approved tools, identify and mitigate bias or inaccuracies, and communicate AI-driven insights clearly and responsibly to peers and managers.
• Demonstrated fluency in both written and spoken English, and in other local language(s), as applicable.