Senior Mechanical Engineer - Medical Devices (Hybrid)

SPD Development Company Ltd; Bedford; Hybrid; GBP 50,000 - 60,000; Full time

Benefits offered by this job

Bonus

Benefits

Job summary

SPD Swiss Precision Diagnostics in Bedford, UK is seeking an experienced Senior Mechanical Engineer to lead the full product lifecycle from concept through to manufacture and launch within a multidisciplinary R&D team.

This hybrid role (3 days on site) involves developing robust, manufacturable designs, managing risk with FMEA, supporting Design Transfer, and coordinating with global suppliers.

Qualifications

• Degree in Mechanical Engineering or related discipline.
• 5+ years in a manufacturing or engineering environment.
• Experience in product development, design transfer and manufacturing / process engineering.
• Experience in regulated industries, ideally medical devices or diagnostics.
• Knowledge of ISO 13485, IVDR and FDA requirements.
• Strong analytical skills including tolerance analysis and FEA.
• Proficiency in 3D CAD software, ideally SolidWorks.
• Excellent communication and technical reporting skills.
• Ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Lead the resolution of complex mechanical engineering challenges.
• Develop innovative product designs using DFM and DFA principles.
• Produce and maintain technical documentation, specifications and reports.
• Lead risk management activities including Risk Assessments and FMEA.
• Plan and oversee testing and validation activities.
• Collaborate with external suppliers and manufacturing partners, including those in China.
• Design and manufacture jigs, fixtures and test equipment.
• Develop scalable prototype assembly and manufacturing processes.
• Conduct engineering analyses including tolerance stack-ups and FEA.
• Create and maintain 3D CAD models and drawings using SolidWorks.
• Manage prototype and tooling development through suppliers.
• Support innovation and patent activities with IP specialists.
• Design and improve manufacturing processes for safety, quality and cost efficiency.
• Lead continuous improvement projects using Six Sigma methodologies.
• Produce manufacturing documentation and work instructions.
• Support Design Transfer and new product introduction activities.
• Investigate manufacturing issues using root cause analysis and CAPA.
• Support process validation, equipment validation and production scale-up.

Skills

Leadership

Stakeholder management

DFM

Tolerance analysis

FMEA

Analytical skills

Communication

Education

Degree in Mechanical Engineering

Tools

SolidWorks

FEA

3D CAD

Job description

SPD Swiss Precision Diagnostics in Bedford, UK is seeking an experienced Senior Mechanical Engineer to lead the full product lifecycle from concept through to manufacture and launch within a multidisciplinary R&D team.

This hybrid role (3 days on site) involves developing robust, manufacturable designs, managing risk with FMEA, supporting Design Transfer, and coordinating with global suppliers.