Full-Time | Flexible Working Hours
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.