Lead R&D Engineer

HERO Recruitment Ltd.; Limerick; On-site; EUR 90,000 - 120,000; Full time

Job summary

HERO Recruitment Ltd. seeks a Lead Research and Development Engineer to guide the technical direction of drug-device combination products, ensuring safety, quality, and regulatory compliance.

You will lead cross-functional teams, influence design decisions, and mentor engineers while advancing an area of expertise within a regulated medical device environment. The role emphasizes leading projects, collaborating with senior leadership, and driving best practices in stability, CMC, and regulatory

Qualifications

• Bachelor’s degree in Engineering with 7 years of relevant experience.
• Experience in Medical Device or regulated industry.
• Project/technical leadership experience.
• Experience working with senior leadership.
• Mentoring and training employees in area of expertise.

Responsibilities

• Lead technical development of medium to large projects/programs.
• Provide technical leadership across multiple projects.
• Identify focus areas with senior leadership for research and best practices.
• Create procedures or white paper guidance for functional groups.
• Mentor engineers and foster knowledge sharing across teams.
• Lead the development and execution of design history files and design decisions to meet customer needs.

Skills

Analytical thinking

Technical writing

Cross-functional teamwork

Product/process development

Regulatory standards (ISO/EU/FDA)

Influencing skills

Project management

AI and data literacy

English fluency

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.

Responsibilities for supporting technical leadership may include:

• Leading technical development of medium to large projects/programs.
• Leading all key design decisions to ensure quality of design selection to meet customer needs.
• Retrospective project reviews to understand lessons learned.
• Implementation of strategic goals within area of expertise.
• Responsibilities for providing subject matter expertise may include:
• Work with senior leadership to identify and agree on focus area(s) for multiple projects across the functional department(s).
• Conduct research and contribute to the development of best practices in focus area(s).
• Create procedures or white paper guidance for functional groups.
• Deploy knowledge, training, and ensure correct implementation of new concepts and/or approaches.
• Work closely with SME’s, physicians, and product managers to develop innovative medical devices to improve patient care, as applicable.
• Lead the activities of medium to large projects/programs and drive project tasks to ensure timely completion of project milestones, and that business metrics are achieved in collaboration with project manager(s) (when one is assigned).
• May also assume responsibility in interpreting data, organizing, executing, and coordinating project activities within portions of projects/programs.
• Lead the development and execute activities and documentation to create and maintain design history files.
• Develops and implements new processes and solutions that will impact the achievement of the department business metrics.
• Drive leading subject matter area specialization across the department, remaining on the forefront of current industry practices, to improve on existing technology, processes, and practices.
• Provide technical and strategic input on company intellectual property relevant to their projects/programs and/or area of expertise to drive innovation and IP generation.
• Lead innovative and creative problem-solving techniques to develop and implement cutting edge medical devices and technologies, overcoming complex engineering challenges and driving product/process excellence to support projects/programs across functional groups.
• Build, communicate, and manage effective relationships with cross functional groups throughout the global organization to achieve business metrics and project milestones.
• Apply the organization’s business processes and systems, as applicable to your duty and responsibilities.
• Ensure with Quality, Regulatory, and company policies and systems.
• Act as a mentor and support engineers fostering an environment of collaborative knowledge sharing and continuous learning.

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.