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Chemical Engineer

2 months ago


Coleraine, United Kingdom Eakin Healthcare Group Full time
About the Role

We are seeking a highly skilled Chemical Engineer to join our R&D team at Eakin Healthcare Group. As a key member of our team, you will be responsible for developing and optimizing chemical formulations and processes for medical devices.

Key Responsibilities
  • Develop and optimize chemical formulations for medical devices, ensuring stability, efficacy, and safety.
  • Design and implement chemical processes for the manufacturing of medical devices, including scaling up from laboratory to production scale.
  • Develop and optimize manufacturing processes for chemical formulations, ensuring efficiency and cost-effectiveness.
  • Oversee the scale-up of processes from R&D to manufacturing, ensuring technology transfer is smooth and compliant with regulatory standards.
  • Conduct experiments and tests on prototypes to evaluate performance, identify issues, and make necessary adjustments.
  • Ensure all processes and formulation testing comply with UK and EU regulations, including MDR (Medical Device Regulation) and ISO standards.
  • Stay updated on changes in regulatory requirements and implement necessary adjustments to processes and documentation.
  • Develop and implement quality control protocols to ensure consistency and safety of chemical formulations.
  • Perform validations of chemical processes.
  • Plan and manage projects related to chemical engineering and formulation manufacture in medical devices, including timelines, resources, and budgets.
  • Work closely with Formulation team, R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams to ensure seamless project execution.
Requirements
  • Bachelor's degree in engineering or life sciences.
  • Experience working within a project team within the medical device industry.
  • Knowledge of medical device Product development processes and regulations, including FDA QSR, ISO 13485, and EU MDR.
  • Ability to inspire and motivate cross-functional teams.
  • Exceptional communication and interpersonal skills, with the ability to engage effectively with stakeholders at all levels.
Competencies
  • Balances Stakeholders: Anticipating and balancing the needs of multiple stakeholders.
  • Action Oriented: Taking on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm.
  • Resourcefulness: Securing and deploying resources effectively and efficiently.
  • Plans and Aligns: Planning and prioritizing work to meet commitments aligned with organizational goals.
  • Ensures Accountability: Holding self and others accountable to meet commitments.
  • Collaborates: Building partnerships and working collaboratively with others to meet shared objectives.
  • Communicates Effectively: Developing and delivering multi-mode communications that convey a clear understanding of the unique needs of different audiences.
  • Instils Trust: Gaining the confidence and trust of others through honesty, integrity, and authenticity.