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
duties 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.

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