End-to-End Device Design Engineer (Medical)

Valtera Group Ltd; Cambridge; Sur place; GBP 50 000 - 70 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

End-to-end design

CAD proficiency

Root cause analysis

Analytical modelling

Tolerance analysis

Design history file

Regulatory knowledge

Technical communication

Travel willingness

Formation

Higher Diploma

Bachelor's degree in mechanical or biomedical engineering

Master's degree in related field

Outils

CAD software (2D drawings)

GD&T knowledge

CFD/FEA (basic)

Description du poste

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.