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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Design Control and management of Design History Files, with a strong focus on leading product development and change control projects in highly regulated life sciences environments. Proven ability to influence cross-functional teams and drive effective solutions through technical leadership and problem-solving skills.
Highest-signal resume keywords
Design Control ManagementChange Control ProjectsRoot Cause AnalysisCAD Software (SolidWorks)ISO 13485 Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Design ControlRisk ManagementProduct DevelopmentRoot Cause AnalysisProject ManagementDesign for ManufacturingDesign for AssemblyContinuous Improvement5 Whys MethodologyFMEA
Soft Skills
Problem-SolvingCommunicationMentoringCollaborationInfluencing
Tools & Technologies
SolidWorksDesign History FilesRegulatory AffairsTechnical ResearchData-Driven Decision Making
Industry Keywords
Medical DevicesDrug Delivery SystemsPharmaceutical ProductsISO 14971FDA 21 CFR Part 820
Tech Stack
Tools & technologiesAssembly
About the role
Key responsibilities & impact- Provide technical leadership for new product development, customer projects, and product lifecycle management activities
- Lead design and development activities in accordance with Design Control and regulatory requirements
- Drive change control projects across existing products, components, materials, packaging, labelling, and manufacturing processes
- Own and maintain Design History Files, risk management documentation, and Design Control records
- Lead technical investigations, root cause analysis activities, CAPAs, and non-conformance assessments
- Make data-driven recommendations and provide clear technical direction for complex engineering challenges
- Collaborate with Operations, Commercial, Quality, Regulatory Affairs, Manufacturing, and external partners
- Influence project teams by challenging assumptions, identifying improvement opportunities, and driving effective solutions
- Support development of more efficient and effective R&D processes and promote best practices
- Apply Design for Manufacturing and Design for Assembly principles to create robust, scalable product designs
- Mentor colleagues and provide technical guidance
- Stay current with industry developments through technical research, publications, patents, supplier engagement, and professional networking
Requirements
What you’ll need- Significant experience in medical devices, drug delivery systems, pharmaceutical products, or another highly regulated life sciences environment
- Strong expertise in Design Control and management of Design History Files (DHFs)
- Proven experience leading product development and change control projects
- Demonstrated ability to make decisions, assess risk, and drive projects forward with minimal supervision
- Experience influencing cross-functional stakeholders and leading technical discussions
- Excellent problem-solving and root cause investigation skills
- Ability to manage multiple concurrent projects and priorities
- Strong written and verbal communication skills in English
- Experience using CAD software, particularly SolidWorks
- Knowledge of ISO 13485, ISO 14971, and FDA 21 CFR Part 820 requirements
- Experience with RCA methodologies including 5 Whys, Ishikawa Diagrams, and FMEA
- Project management experience
- Experience improving engineering or development processes through simplification, efficiency, or continuous improvement initiatives
- Bachelor's degree or higher in Mechanical Engineering, Systems Engineering, Design Engineering, Medical Engineering, or another relevant STEM discipline
- Willingness and ability to travel up to 10% of the time, mostly within Europe, with overseas travel expected
- Ability to work with flexibility across the working day when collaborating with non-UK-based colleagues
Benefits
Comp & perks- Remote working with occasional onsite work at Deeside’s Global Development Centre
- Travel opportunities, including overseas travel
- Opportunity to influence product strategy and new product development
- Mentoring and technical guidance opportunities
- Collaboration with cross-functional and global teams
- Professional networking, technical research, publications, and patent involvement
