Device Design Engineer

Valtera Group Ltd; Cambridge; On-site; GBP 50,000 - 70,000; Full time

Job summary

Valtera Group Ltd in Cambridge is seeking a Device Design Engineer to lead end-to-end design and industrialisation of combination products from concept through to design transfer.

You will work in cross-functional teams, applying GD&T, creating detailed drawings, performing analyses, and ensuring documentation aligns with ISO 13485 and medical device regulations. Travel to UK and Ireland sites is required.

Qualifications

• End-to-end combination product experience from concept to design transfer.
• Degree in product design, mechanical or biomedical engineering (2.1 or higher).
• Strong CAD proficiency and GD&T understanding.
• Experience with root cause analysis, hand calculations, analytical modelling and tolerance stack-up.
• Experience creating and reviewing Design History File documentation, component drawings, change controls and BOM management.
• Familiarity with ISO 13485 and medical device regulations.
• Clear technical communication and stakeholder management.
• Willingness to travel regularly between sites in the UK and Ireland, with occasional international travel.

Responsibilities

• Develop combination products from concept generation through to design transfer.
• Produce fully dimensioned 2D drawings and specifications, applying GD&T to ensure manufacturable designs.
• Resolve design challenges using root cause analysis, hand calculations, tolerance analysis, CFD and FEA.
• Represent device design within cross-functional programme teams, supporting planning and execution of design activities.
• Identify, assess and mitigate technical risks in line with ISO 14971, including hazard analysis and dFMEAs.
• Create, review and approve Design History File documentation, including change controls, BOMs and technical reports.
• Build and test prototype components and devices, using data to refine and improve designs.
• Deliver right first time submission packages and close out peer review feedback.

Skills

End-to-end design

CAD proficiency

Root cause analysis

Analytical modelling

Tolerance analysis

Design history file

Regulatory knowledge

Technical communication

Travel willingness

Education

Higher Diploma

Bachelor's degree in mechanical or biomedical engineering

Master's degree in related field

Tools

CAD software (2D drawings)

GD&T knowledge

CFD/FEA (basic)

Job description

Design and deliver combination products from concept through to design transfer

A global pharmaceutical company is hiring a Device Design Engineer into its device design and industrialisation function, based in Cambridge. The role supports a portfolio of programmes including complex injectables and feasibility projects. You will work within cross-functional programme teams, taking technical ownership of design and documentation through to stage gates and regulatory submission milestones. The impact is high-quality, right first time submissions and robust, manufacturable devices.

What You Will Do

• Develop combination products from concept generation through to design transfer.
• Produce fully dimensioned 2D technical drawings and specifications, applying GD&T to ensure manufacturable designs.
• Resolve design challenges using root cause analysis, hand calculations, tolerance analysis, CFD and FEA.
• Represent device design within cross-functional programme teams, supporting planning and execution of design activities.
• Identify, assess and mitigate technical risks in line with ISO 14971, including hazard analysis and dFMEAs.
• Create, review and approve Design History File documentation, including change controls, BOMs and technical reports.
• Build and test prototype components and devices, using data to refine and improve designs.
• Deliver right first time submission packages and close out peer review feedback.

What We're Looking For

• Design engineering or product development background, with end-to-end combination product experience from concept to design transfer.
• Higher Diploma, Bachelor's or Master's degree (2.1 or higher) in product design, mechanical or biomedical engineering, or a related science.
• Strong CAD proficiency, including detailed 2D drawings and a thorough understanding of GD&T.
• Hands-on experience with root cause analysis, hand calculations, analytical modelling and tolerance stack-up analysis.
• Experience creating and reviewing Design History File documentation, component drawings, change controls and BOM management.
• Working knowledge of ISO 13485 quality management systems and design controls aligned with medical device regulations.
• Clear technical communication and stakeholder management across multidisciplinary teams.
• Willingness to travel regularly between sites in the UK and Ireland, with occasional international travel.