Senior R&D Engineer
Posted 7 days ago by Real
£55 Per hour
Undetermined
Remote
West Yorkshire, England, United Kingdom
Summary: A global medical device company is seeking a Senior R&D Engineer for a 6-month contract to support late-stage product development and launch readiness. The role involves working with a cross-functional team across the UK and US, focusing on Design History File documentation and marketing claims. The position is predominantly remote, with initial onboarding at a UK site.
Key Responsibilities:
- Support late-stage product development and launch readiness for a medical device system.
- Focus on Design History File documentation and marketing claims.
- Collaborate with cross-functional teams including engineering, regulatory, clinical, and marketing.
- Create technical writing and evidence summaries.
Key Skills:
- Medical device product development experience.
- Design History File / DHF documentation experience.
- MDR and FDA 510(k) knowledge.
- Technical writing and evidence summary creation.
- Cross-functional communication skills.
- Experience with implantable devices or surgical instruments (desirable).
- Experience creating marketing claims and launch documentation (desirable).
Salary (Rate): £55.00/hr
City: West Yorkshire
Country: United Kingdom
Working Arrangements: remote
IR35 Status: undetermined
Seniority Level: Senior
Industry: Other
A global medical device company working on a new product launch is seeking an experienced Medical Device Engineer to support on a 6-month contract basis, starting as soon as possible. You'll work with a cross-functional development team across the UK and US to support late-stage product development and launch readiness. The role will focus on Design History File documentation, marketing claims, supporting evidence summaries, and process documentation for a medical device system with both device and instrument elements. Aside from initial onboarding at a UK site, the role will be predominantly remote.
Essential Skills
- Medical device product development experience
- Design History File / DHF documentation experience
- MDR and FDA 510(k) knowledge
- Technical writing and evidence summary creation
- Cross-functional communication with engineering, regulatory, clinical, and marketing teams
Desirable Skills
- Experience with implantable devices, surgical instruments, or complex medical device systems
- Experience creating marketing claims, launch documentation, or procedural documentation
This is a strong fit for engineers who are confident owning design documentation, pulling together compliant evidence, and working with global teams to support late-stage medical device launch activity.
Desired Skills and Experience
- Medical Device Product Development
- Design History File
- DHF Documentation
- MDR
- FDA 510(k)
- Regulatory Documentation
- Technical Writing
- Evidence Summary Creation
- Marketing Claims
- Claims Substantiation
- Launch Documentation
- Process Documentation
- Surgical Process Documentation
- Procedural Documentation
- Design Documentation
- Design Controls
- Risk Management
- Verification and Validation
- V&V Documentation
- Cross-Functional Communication
- Regulatory Affairs
- Quality Assurance
- Clinical Evidence
- Engineering Documentation
- Late-Stage Development
- Product Launch
- Global Team Collaboration
- UK/US Stakeholder Management
- Remote Working
- Implantable Devices
- Surgical Instruments
- Complex Medical Device Systems
Please click here to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.
To find out more about Real, please visit www.realstaffing.com Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office | 8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC387148 England and Wales