Device Compliance Engineer

Use Your Power for Purpose
At Pfizer, our purpose is to deliver breakthroughs that change patients' lives. Central to this mission is our Research and Development team, which is dedicated to translating advanced science and innovative technologies into the therapies and vaccines that matter most. Whether you are involved in discovery sciences, ensuring drug safety and efficacy, or supporting clinical trials, you will leverage cutting-edge design and process development capabilities to accelerate the delivery of best-in-class medicines to patients worldwide.
This position is in the Biotherapeutics Pharmaceutical Research and Development Devices Centre of Excellence located in Cambridge, UK. The incumbent will provide design control and risk management subject matter expertise to medical device and combination product development programmes throughout the product lifecycle. This will involve generation and review of design history file and risk management file components whilst interacting with cross functional development teams at all levels of the organization.
What You Will Achieve
In this role, you will:

• Lead design control and risk management activities for combination product development programs, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
• Support and facilitation of 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 assistance to design validation including, but not limited to, human factors engineering assessments.
• Assist the assessment of external design companies and suppliers for capability of quality systems, facilities, and procedures to assist device development and supply.
• Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture.
• Support the generation of all regulatory submission data and content for assigned device projects.
• Assist internal and external audits of the DCoE Quality Management System.
• Identify, communicate, and develop strategies to improve combination product systems.

Here Is What You Need (Minimum Requirements)

• BSc in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline) with strong 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 strong relevant experience in the pharmaceutical combination product and/or device industries

OR

• PhD in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline).
• 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 controls for combination products.
• Device risk management expertise.
• Familiar with Human Factors Engineering - Usability Engineering.
• Comprehend project management methodologies and capable to provide technical leadership for projects.
• Familiar with device assembling manufacturing processes.
• Ability to perform to perform complex data analysis.

Bonus Points If You Have (Preferred Requirements)

• Thorough working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
• Working knowledge of 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 tasks.
• Able to work collaboratively in cross functional teams.
• Excellent communication (e.g., oral, written, presentation) and social skills.
• Proficiency in general computer software such as word processing, spreadsheets, presentations.
• Knowledge of Good Manufacturing Practices (GMP).

Work Location Assignment: Hybrid (some office presence is required)
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
DisAbility Confident
We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!
Research and Development