Senior Mechanical Engineer

Get Staffed Online Recruitment Limited; Bedford; Híbrido; GBP 70.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

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

Descripción de la vacante

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.

Formación

• 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).

Responsabilidades

• 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.

Conocimientos

DFM & DFA

SolidWorks

FMEA

Risk assessment

DOE / DoE

Six Sigma

Regulatory knowledge ISO 13485/FDA

Root cause analysis

Educación

Bachelor's degree in Mechanical Engineering

Herramientas

FEA (Finite Element Analysis)

Descripción del empleo

Our client is looking for an experienced and innovative Senior Mechanical Engineer to help develop the next generation of fertility and pregnancy products. Based in Bedford, you will play a key role in product development from concept through to manufacture and launch, working within a multidisciplinary R&D team.

This is an exciting opportunity for an Engineer who enjoys solving technical challenges, driving innovation and contributing to products that positively impact people's lives.

About Our Client

Our client is a global leader in consumer diagnostics. Their brand is recognised worldwide for accurate home pregnancy and fertility monitoring products.

The Role

As a Senior Mechanical Engineer, you will provide technical leadership across the full product lifecycle, from concept development and prototyping through to manufacture and product launch. You will work closely with cross-functional teams and external partners to develop robust, manufacturable designs while ensuring compliance with quality and regulatory standards.

You will also support process engineering activities, helping transfer new products into manufacturing and drive continuous improvement initiatives.

Key Responsibilities

Mechanical Engineering:

• 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.

Process Engineering:

• 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.

About You

• Degree in Mechanical Engineering or a related discipline.
• 5+ years' experience in a manufacturing or engineering environment.
• Experience in product development, design transfer and manufacturing / process engineering.
• Experience working within 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.
• Knowledge of process and equipment validation.
• Experience applying DFM and DFA principles.
• Understanding of DoE, Six Sigma and continuous improvement tools.
• Experience supporting manufacturing optimisation and regulatory compliance.

What You'll Bring:

• Proactive problem-solving approach.
• Strong leadership and stakeholder management skills.
• Ability to influence technical decisions and deliver results.
• Passion for innovation and engineering excellence.

Additional Information:

• International travel required several times per year.

What Our Client Offers:

• Hybrid working (3 days on site, 2 from home)
• 25 days annual leave plus bank holidays
• Private Medical Insurance and medical cash plan
• Enhanced maternity and paternity pay
• Health and Wellbeing programme
• Life assurance
• Free electric vehicle charging
• Attractive parkland location with excellent links to Cambridge, Milton Keynes and London