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- Tasks: Lead design control and risk management for medical device development, ensuring compliance and quality.
- Company: TekWissen is a global workforce management provider, partnering with a leading pharmaceutical corporation.
- Benefits: Enjoy a 12-month onsite role with opportunities for professional growth in a dynamic environment.
- Why this job: Join a team that impacts healthcare through innovative medical devices and fosters collaboration across disciplines.
- Qualifications: BSc or MSc in relevant science/engineering with 5+ years in pharmaceutical/device industries required.
- Other info: Ideal for those passionate about regulatory standards and making a difference in biotherapeutics.
The predicted salary is between 36000 - 60000 £ per year.
This position is in the Biotherapeutics Pharmaceutical Research and Development (Drug Product Design and Development) located in Cambridge, UK. The incumbent will provide design control and risk management subject matter expertise to medical device combination product development programmes throughout the product lifecycle.
This will involve ensuring consistent implementation of applicable processes and standards across the portfolio, in addition to the facilitation and documentation of specific design control and risk management activities, whilst interacting with cross functional development teams at all levels of the organisation.
Position 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 client manufacturing facilities/CMOs related to assigned projects.
- Generation, approval, and retention of client 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.
Key groups and stakeholders the position interacts with:
- 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.
Education Requirements:
- BSc in an appropriate science & engineering discipline (e.g. chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering) with a minimum of 5 years of relevant experience in the pharmaceutical combination product and/or device industries.
- MSc in the above disciplines with a minimum of 5 years of relevant experience.
- Experience working under ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and EU Medical Devices Regulation.
- Proven expertise in design control and risk management for medical device combination products and/or medical devices.
- Familiarity with Human Factors Engineering (Usability Engineering).
- Understanding of device assembly and manufacturing processes.
- Working knowledge of relevant standards: ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, EU Medical Devices Regulation.
- Familiarity with EN 62366, EN 60601, and EN 62304.
- Strong adherence to established procedures with attention to technical detail and accuracy.
- Ability to work independently and collaboratively in cross-functional teams.
- Capable of handling multiple responsibilities and tasks simultaneously.
- Excellent communication and interpersonal skills.
- Proficient with general office software (e.g., Word, Excel, PowerPoint).
- Knowledge of Good Manufacturing Practices (GMP).
- Sitting
- Ability to travel
- Driving license required
- Decisive: Agile learner who synthesizes complex information to determine the best course of action.
- Focused: Holds self and others accountable for consistently meeting needs of customers and stakeholders.
- Connected: Builds effective professional relationships with internal and external stakeholders.
- Courageous: Shows consistency between words and actions, gaining people's trust and respect.
- Resilient: Adapts or shifts priorities in response to the needs of clients, constituents, or the organization.
Design Control and Risk Management Compliance Engineer employer: LinkedIn
Contact Detail:
LinkedIn Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Design Control and Risk Management Compliance Engineer
✨Tip Number 1
Familiarise yourself with the specific regulations and standards mentioned in the job description, such as ISO 13485 and ISO 14971. Being able to discuss these in detail during your interview will demonstrate your expertise and commitment to compliance.
✨Tip Number 2
Network with professionals in the pharmaceutical and medical device industries, especially those who have experience in design control and risk management. This can provide you with valuable insights and potentially lead to referrals for the position.
✨Tip Number 3
Prepare to showcase your experience with cross-functional teams. Think of examples where you've successfully collaborated with different departments, as this role requires strong interpersonal skills and teamwork.
✨Tip Number 4
Stay updated on the latest trends and advancements in biotherapeutics and medical devices. Being knowledgeable about current developments can help you stand out as a candidate who is passionate and informed about the industry.
We think you need these skills to ace Design Control and Risk Management Compliance Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in design control and risk management, particularly in the pharmaceutical and medical device sectors. Use keywords from the job description to demonstrate your fit for the role.
Craft a Compelling Cover Letter: Write a cover letter that specifically addresses the responsibilities outlined in the job description. Explain how your background in ISO standards and your experience with medical device combination products make you an ideal candidate.
Showcase Relevant Skills: In your application, emphasise your technical skills related to ISO 13485, ISO 14971, and other relevant regulations. Provide examples of how you've successfully implemented these standards in past projects.
Highlight Collaborative Experience: Since the role involves working with cross-functional teams, include examples of your collaborative work in previous positions. Mention any specific projects where you led or contributed to design control and risk management activities.
How to prepare for a job interview at LinkedIn
✨Know Your Standards
Familiarise yourself with ISO 13485, ISO 14971, and other relevant regulations. Be prepared to discuss how you've applied these standards in your previous roles, as this will demonstrate your expertise in design control and risk management.
✨Showcase Your Experience
Highlight your experience in the pharmaceutical combination product and device industries. Prepare specific examples of projects where you led design control activities or managed risk assessments, as this will illustrate your hands-on knowledge.
✨Emphasise Collaboration Skills
Since the role involves working with cross-functional teams, be ready to share examples of how you've successfully collaborated with different stakeholders. This could include working with engineers, quality assurance, or external partners.
✨Prepare for Technical Questions
Expect technical questions related to design validation and usability engineering. Brush up on your knowledge of human factors and be ready to discuss how you ensure compliance with quality and regulatory standards in your work.
