- Company Name
- Owen Mumford
- Job Title
- Senior Design Engineer - Research
- Job Description
-
**Job Title:** Senior Design Engineer – Research
**Role Summary:**
Lead end‑to‑end design of medical device prototypes and production models, collaborating with cross‑functional teams (customers, manufacturing, quality, regulatory). Drive project delivery, design innovation, and compliance with ISO 13485/FDA standards.
**Expectations:**
- Deliver design projects independently, on time and to high quality.
- Act as technical liaison in customer meetings and internal design reviews.
- Mentor junior engineers and maintain a robust intellectual‑property pipeline.
**Key Responsibilities:**
- Manage full product life‑cycle design activities, from concept generation to design transfer.
- Create detailed 3‑D and 2‑D CAD models (SolidWorks), surface‑modeling, and manufacturing drawings, ensuring tolerance and manufacturability.
- Conduct design analysis: FMEA, tolerance, and mechanical/thermal FEA (Abaqus).
- Lead design reviews, verification, validation, and change control documentation (DDF, DVP, DVC, DHF).
- Integrate human‑factors requirements; collaborate with HFE specialists to compile background documents and support usability studies.
- Interface with industrialisation teams to optimise design for manufacture and assembly.
- Engage customers in technical discussions, requirement gathering, and progress updates.
- Support regulatory compliance (GMP, ISO 13485, FDA 820.30) through accurate design documentation.
**Required Skills:**
- Advanced SolidWorks (3‑D modeling, surfacing, 2‑D detailing).
- Strong understanding of injection‑molded plastic parts, tooling, and manufacturing processes.
- Proficient in risk assessment – FMEA, hazard analysis.
- Experience with FEA (Abaqus) and tolerance analysis tools.
- Ability to produce clear technical reports, presentations, and documentation.
- Excellent communication, presentation, and stakeholder‑management skills.
- Proficient in MS Office (Excel, Word, PowerPoint).
**Required Education & Certifications:**
- Bachelor’s (or advanced) degree in Mechanical Engineering, Bioengineering, or related discipline.
- Proven experience in regulated medical device development (ISO 13485/FDA 820.30).
- Familiarity with GMP processes and design‑control documentation.
Woodstock, United kingdom
On site
Senior
01-03-2026