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A leading company in the Pharmaceutical located in Cambridge is seeking a Design Engineer This role involves providing subject matter expertise in design control and risk management for medical device combination product development programmes throughout the product lifecycle. The Design Control and Risk Management Specialist will ensure consistent implementation of applicable processes and standards across the portfolio, facilitate and document specific design control and risk management activities, and interact with cross-functional development teams at all levels of the organisation.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Design Engineer will be varied however the key duties and responsibilities are as follows:
1. Lead design control and risk management activities for medical device combination product development programmes, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
2. Support and facilitate effective design control and risk management activities internally, at external design companies, and at manufacturing facilities related to assigned projects.
3. Generate, approve, and retain design control and risk management documentation ensuring that quality and regulatory requirements are satisfied.
4. Ensure medical device combination product design control and risk management activities are compliant with quality and regulatory standards, both internal and external.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the Design Control and Risk Management Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a science or engineering discipline (e.g., chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering).
2. Extensive industry experience in pharmaceutical combination product and/or device industries.
3. A working knowledge and practical experience with ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
Key Words:
Design Control / Risk Management / Medical Device / Combination Product / Pharmaceutical / Biotherapeutics / Quality Assurance / Regulatory Compliance / Cambridge / Drug Product Development / Design engineer / Risk management / Compliance
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
A leading company in the Pharmaceutical located in Cambridge is seeking a Design Engineer This role involves providing subject matter expertise in design control and risk management for medical device combination product development programmes throughout the product lifecycle. The Design Control and Risk Management Specialist will ensure consistent implementation of applicable processes and standards across the portfolio, facilitate and document specific design control and risk management activities, and interact with cross-functional development teams at all levels of the organisation.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Design Engineer will be varied however the key duties and responsibilities are as follows:
1. Lead design control and risk management activities for medical device combination product development programmes, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
2. Support and facilitate effective design control and risk management activities internally, at external design companies, and at manufacturing facilities related to assigned projects.
3. Generate, approve, and retain design control and risk management documentation ensuring that quality and regulatory requirements are satisfied.
4. Ensure medical device combination product design control and risk management activities are compliant with quality and regulatory standards, both internal and external.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the Design Control and Risk Management Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a science or engineering discipline (e.g., chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering).
2. Extensive industry experience in pharmaceutical combination product and/or device industries.
3. A working knowledge and practical experience with ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
Key Words:
Design Control / Risk Management / Medical Device / Combination Product / Pharmaceutical / Biotherapeutics / Quality Assurance / Regulatory Compliance / Cambridge / Drug Product Development / Design engineer / Risk management / Compliance
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
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