Eurofins Scientific is an international life sciences company that delivers analytical testing services to secure the safety and integrity of food, water, medicines, and more. The Device Engineering group is looking for a dedicated professional to support design control and risk management activities for medical device and combination product development across the product lifecycle.
Job Overview
This full‑time, permanent position requires a flexible 37‑hour work week, Monday to Friday. The role involves working closely with cross‑functional development teams, ensuring compliance with ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, EU MDR, and related standards.
Responsibilities
* Lead design control and risk management activities for combination product development programmes, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
* Support and facilitate effective risk management activities at external design companies and manufacturing facilities related to assigned projects.
* Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external.
* Provide input and support to design validation, including human factors engineering assessments.
* Support assessment of external design companies and suppliers for capability of quality systems, facilities, and procedures to support device development and supply.
* Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture.
* Support generation of all regulatory submission data and content for assigned device projects.
* Support internal and external audits of the client’s DCoE Quality Management System.
* Identify, communicate, and develop strategies to improve combination product systems.
* Contribute to systems‑based limited duration teams across the client organisation.
Qualifications
* BSc, MSc or PhD in an appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering, or related discipline).
* Relevant experience in the pharmaceutical combination product and/or device industries.
* Experience working in accordance with ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and EU MDR.
* Experience in design controls for combination products.
* Experience of device risk management expertise.
* Familiar with Human Factors Engineering – Usability Engineering.
* Understanding of project management methodologies and ability to provide technical leadership for projects.
* Familiar with device assembling manufacturing processes.
* Ability to perform complex data analysis.
* Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and EU MDR.
* Working knowledge of EN 62366, EN 60601, and EN 62304.
* Ability to learn and apply established procedures reliably.
* Capability to work independently with minimal supervision.
* High level of attention to technical detail and accuracy.
* Ability to prioritise multiple responsibilities and handle multiple tasks simultaneously.
* Excellent communication and interpersonal relationship skills.
* Proficiency in general computer software (word processing, spreadsheets, presentations).
* Understanding of Good Manufacturing Practices (GMP).
Additional Information
* Reward and Recognition programmes.
* Health Cash Plan.
* Life Assurance (4× annual salary).
* Company Pension Plan.
* Employee Assistance Programme – 24/7 confidential support.
* Free car parking.
* Worldwide career opportunities.
* Perkbox membership for savings across daily life.
What Happens Next
Qualified candidates will be invited to an assessment centre or a staged interview process based on the role and its requirements, giving you the chance to experience working for Eurofins and allowing us to understand your key skills and strengths.
Your Data
As part of the recruitment process we collect and process personal data related to job applicants. Eurofins is committed to transparency, data protection and meeting all applicable obligations.
We Embrace Diversity!
Eurofins is an Equal Opportunity Employer and prohibits discrimination based on gender identity, race, nationality, age, religion, sexual orientation, disability, or any characteristic that creates diversity. We support armed forces veterans, reservists and related groups.
Sustainability Matters to Us
We are working toward carbon neutrality by 2025, with initiatives to reduce emissions, compensate for residual impact, and encourage laboratory leaders to adopt sustainable practices.
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