Chemical Engineer

Eakin Healthcare Group; Coleraine; On-site; GBP 35,000 - 50,000; Full time

Job summary

A leading healthcare company in Northern Ireland is looking for a key contributor within their R&D team to drive projects related to chemical engineering for medical devices. The role involves developing and optimising chemical formulations while ensuring compliance with regulatory standards such as MDR and ISO. Candidates should have a relevant Bachelor's degree and experience in project management within the medical device sector.

Qualifications

• Experience in the medical device industry.
• Knowledge of FDA QSR, ISO 13485, EU MDR.
• Evidence of leading complex Medical Device Development projects.

Responsibilities

• Develop and optimise chemical formulations for medical devices.
• Design chemical manufacturing processes and ensure regulatory compliance.
• Plan and manage projects related to chemical engineering.

Skills

Communication

Team Leadership

Project Management

Problem Solving

Education

Bachelor's degree in engineering or life sciences

Tools

Project management tools

Job description

Social network you want to login/join with:

At Eakin Healthcare we put our patient at the heart of everything we do.

Fifty years ago, it all started with one man’s mission: pharmacist, Tom George Eakin. He saw his patients struggling with leaking urostomy pouches and decided enough was enough. He got to work and formulated what would become the game-changing, eakin Cohesive seal.

Fast forward to today, and we’re still keeping it in the family. We’ve grown a lot since then, both organically and through acquisitions. We now have a team of over 700 colleagues across three manufacturing sites and 12 sales and distribution centres. We’re making a difference in three therapeutic areas:

• Ostomy
• Respiratory
• Surgical

We’re proud to export our innovative products to over 60 countries through a network of 40 distributors plus our own offices in Japan, The Netherlands, France, Germany, Belgium and Luxemburg.

We’re good at what we do – come and join us!

ABOUT THE ROLE

Reporting to the Director of Development this is an exciting opportunity to build a key position within the R&D team. Central to the role will be the execution of projects related to chemical engineering and chemical formulations to enable business growth, whilst exceeding customer expectations. The successful applicant will be required to plan and execute those programmes, with accountability for overall governance and reporting to senior leadership teams.

KEY ACTIVITIES

• Develop and optimise chemical formulation production, particularly inorganic compounds, 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 optimise 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.
• Conduct research to explore new inorganic materials, technologies, and methods to enhance the performance and safety of medical devices with relevant Therapeutic areas.

KEY SKILLS

• 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
• Evidence of successfully leading large-scale, complex Medical Device Development projects from initiation to commercialization
• Proficiency in project management tools and software

KEY WORKING RELATIONSHIPS

This role interacts with stakeholders across all of Eakin Healthcare and will have an influencing role with the following:

Internal

• Clinical and Regulatory, Innovation, Development
• Commercial
• Operations to include Manufacturing, Facilities and Procurement
• Finance

External

Manage the outputs from:

• Key suppliers of equipment and components.
• Contractors and specialists such as Design houses & IT system suppliers.

ADDITIONAL INFORMATION

• Able to travel frequently between our various locations and occasional international travel.

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.