Design Control And Risk Management Compliance Engineer

SRG; Cambridge; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading engineering recruitment agency is seeking a Design Control and Risk Management Compliance Engineer for a 12-month contract in Cambridge. The candidate will lead design control activities for medical device development, ensuring compliance with quality and regulatory standards. Required qualifications include a BSc or MSc in a relevant discipline and at least 5 years of industry experience. This role offers a pay rate of up to £20.79 per hour depending on experience.

Qualifications

• Minimum of 5 years of relevant experience in the pharmaceutical combination product and/or device industries.
• Experience in design control and risk management for medical devices.
• History of working in accordance with ISO 13485 and other relevant regulations.

Responsibilities

• Lead design control and risk management activities for medical device development.
• Ensure compliance with quality and regulatory standards.
• Support the generation of regulatory submission data.

Skills

Familiar with Human Factors Engineering - Usability Engineering

High level of attention to technical details

Excellent communication skills

Education

BSc in appropriate science & engineering discipline

Tools

General computer software (word processing, spreadsheets)

Job description

Overview

Job Title: Design Control and Risk Management Compliance Engineer. Contract: 12 months. Hours:37 hrs p/w. Location: Cambridge. Pay rate: up to £20.79 p/h DOE.

Responsibilities

• 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.
• Support and facilitation of effective design control and risk management activities internally, at external design companies, and at the business manufacturing facilities/CMOs related to assigned projects.
• Generation, approval, and retention of business' design control and risk management documentation ensuring that quality and regulatory requirements are satisfied.
• Ensure medical device combination product design control and risk management activities are compliant with quality and regulatory standards, both internal and external.
• Provide input and support to design validation including, but not limited to, use-related risk assessments.
• Support the generation of all regulatory submission data and content for assigned medical device combination product projects.
• Support internal and external audits of the Biotherapeutics Pharmaceutical Research and Development Quality Management Systems.

Organizational Relationships

• Device development teams - Drug Product leads, packaging engineers, medical device combination product engineers, device development leads, human factors SMEs, design engineers and device analytical scientists.
• Co-development team - drug product and device SMEs.
• Quality Assurance
• GCMC (Regulatory)
• PGS - manufacturing sites and post launch device team.
• External designers and contract manufacturing organizations.

Qualifications

• BSc in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline) with a minimum of 5 years of relevant experience in the pharmaceutical combination product and/or device industries OR
• MSc in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline) with a minimum of 5 years of relevant experience in the pharmaceutical combination product and/or device industries
• History of working in accordance with the requirements of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
• Experience in design control for medical device combination products and/or medical devices
• Experience in risk management for medical device combination products and/or medical devices.
• Familiar with Human Factors Engineering - Usability Engineering.
• Familiar with device assembling manufacturing processes.

Technical Skills Requirements

• Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
• Familiarity EN 62366, EN 60601, and EN 62304.
• Able to learn and apply established procedures in a reliable and consistent manner.
• Capable of working independently with minimal supervision.
• High level of attention to technical details and accuracy.
• Able to prioritize multiple responsibilities and to work on multiple tasks simultaneously.
• Able to work collaboratively in cross functional teams.
• Excellent communication (e.g., oral, written, presentation) and interpersonal relationship skills.
• Proficiency in general computer software such as word processing, spreadsheets, presentations.
• Understand Good Manufacturing Practices (GMP).