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Senior R&D NPI Project Engineer Medical Devices
New Today
Opportunity via Clinical Selection
Clinical Selection is partnering with a growing and highly innovative medical device manufacturer seeking a Senior R&D NPI Project Engineer to lead complex new product introduction (NPI) and design transfer programmes.
This is a senior-level role offering significant technical ownership, cross-functional leadership, and the opportunity to drive innovation across a diverse medical device portfolio, including products used within wound care and other regulated therapeutic areas.
The Role As Senior R&D NPI Project Engineer, you will take responsibility for the delivery of complex product development and design transfer projects from concept through to production scale-up.
You will provide technical leadership across engineering, quality, regulatory, manufacturing and customer-facing teams, ensuring robust design control, risk management, compliance and timely execution.
Key responsibilities include:
Leading NPI and design transfer projects to meet scope, cost, quality and timeline commitments
Acting as the senior engineering interface for customers during development and transfer activities
Owning design outputs and manufacturing documentation (BOMs, drawings, DMRs, inspection and manufacturing procedures)
Ensuring design control and technical standards are embedded into all product development work
Driving and owning risk management strategy in line with ISO 14971
Supporting process validation activities (IQ/OQ/PQ) to ensure manufacturing readiness
Partnering cross-functionally with Quality and Regulatory teams to support product registration and launch
Leading engineering changes across the product lifecycle, including legacy support
Participating in supplier selection, technical reviews, qualification and audits
Acting as technical authority during scale-up, validation and early production
Driving continuous improvement using manufacturing data, field feedback and post-market insights
Mentoring and developing junior engineers, providing technical guidance and coaching
Contributing to novel IP generation and innovation initiatives
Essential Experience & Skills Strong background in regulated product development environments (medical devices preferred)
Demonstrated experience leading design transfer and NPI projects into manufacturing
Excellent understanding of design controls, validation and risk-based engineering decision-making
Hands-on experience with quality tools (FMEA, process validation, root cause investigations)
Ability to generate, review and approve technical documentation to a high standard
Confident technical leader, able to influence stakeholders without direct authority
Strong customer-facing communication and issue resolution skills
Proven ability to manage technical, quality and delivery risks independently
Experience with Design for Manufacturability (DFM) and Design for Assembly (DFA) principles
Proficiency in CAD tools such as SolidWorks or equivalent
Desirable Experience Experience acting as technical lead on complex regulated medical device programmes
Familiarity with regulatory submissions (FDA, CE marking) from an engineering perspective
Supplier technical audit and qualification involvement
Exposure to wound care technologies or related product areas
Advanced statistical or process capability knowledge
Qualifications Engineering Degree (or HNC/HND with substantial industry experience)
Typically 58+ years experience in regulated product development and design transfer roles
Why Apply? Senior technical leadership role within an innovative R&D and manufacturing environment
Opportunity to lead critical NPI projects with global regulatory impact
High level of ownership, autonomy and influence across product strategy
Supportive culture with clear scope for progression and mentoring responsibility
Apply in Confidence To discuss this opportunity confidentially, contact Clinical Selection , specialists in medical device and regulated engineering recruitment across the UK.
?? Apply today to be considered.
TPBN1_UKTJ
- Location:
- Nottingham
- Salary:
- £70,000
- Job Type:
- FullTime
- Category:
- Science;Management;Engineering;Engineering;Engineering;Science;Engineering