Senior Mechanical Engineer - Fertility Diagnostics (Hybrid)

Get Staffed Online Recruitment Limited; Bedford; Hybrid; GBP 70,000 - 90,000; Full time

Benefits offered by this job

Hybrid working (3 days on site, 2 from

25 days annual leave plus bank

Private Medical Insurance

Medical cash plan

Enhanced maternity and paternity pay

Health and Wellbeing programme

Life assurance

Electric vehicle charging

Parkland location with links to major

Job summary

Get Staffed Online Recruitment Limited is recruiting for a Bedford-based client to appoint a Senior Mechanical Engineer for fertility and pregnancy diagnostics. You will lead cross-functional development from concept through manufacture, ensuring robust, manufacturable designs within a regulated framework.

The role involves managing design transfer, process engineering, and collaboration with suppliers, with hybrid on-site/remote work and a focus on innovation and engineering excellence.

Qualifications

• Degree in Mechanical Engineering or related field.
• 5+ years in manufacturing or engineering environment.
• Experience in regulated industries, ideally medical devices or diagnostics (ISO 13485, IVDR, FDA).

Responsibilities

• Lead full lifecycle mechanical design from concept to launch.
• Develop manufacturable designs using DFM/ DFA principles.
• Produce technical documentation, specifications and reports.
• Lead risk management activities including FMEA.
• Plan and oversee testing and validation activities.
• Collaborate with external suppliers and manufacturing partners.
• 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.
• 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

DFM & DFA

SolidWorks

FMEA

Risk assessment

DOE / DoE

Six Sigma

Regulatory knowledge ISO 13485/FDA

Root cause analysis

Education

Bachelor's degree in Mechanical Engineering

Tools

FEA (Finite Element Analysis)

Job description

Get Staffed Online Recruitment Limited is recruiting for a Bedford-based client to appoint a Senior Mechanical Engineer for fertility and pregnancy diagnostics. You will lead cross-functional development from concept through manufacture, ensuring robust, manufacturable designs within a regulated framework.

The role involves managing design transfer, process engineering, and collaboration with suppliers, with hybrid on-site/remote work and a focus on innovation and engineering excellence.