Mechanical Engineer - Medical Devices

People Projects (South West) Ltd; Cambridge; On-site; GBP 45,000 - 60,000; Full time

Benefits offered by this job

Office near Cambridge train station

Competitive salary

Job summary

ACT Medical, based in Cambridge, seeks a Mechanical Engineer to take a lab prototype manufacturing tool through to production-ready equipment. You will own one tool end-to-end, from specification and component selection to qualification, while also contributing to B.O.B device development within an ISO 13485 framework.

You will work with the Head of Technology in a small, motivated team in a startup-like environment, with hands-on design, testing, and documentation responsibilities to support

Qualifications

• A degree in mechanical engineering or equivalent demonstrable experience.
• Proven experience in mechanical design from concept to production and creating test rigs.

Responsibilities

• Own the development of one manufacturing tool from spec to formal qualification.
• Build and run V&V tests and help write protocols.
• Support design transfer to contract manufacturer and prepare regulatory documentation.

Skills

Mechanical design

Hands-on prototyping

Regulated development

Documentation

Education

Degree in mechanical engineering

Equivalent demonstrable experience

Tools

SolidWorks

Job description

Our Client ACT Medical develops innovative medical devices that revolutionise the treatment of catastrophic haemorrhage. B.O.B will prevent haemorrhage and is designed to save lives in for both civilian pre-hospital care and battlefield use.

We are currently seeking a Mechanical Engineer to take their working lab prototype manufacturing tools through to production ready equipment. You will be joining small motivated and dynamic team, based in Cambridge.

The Role

You will own one of our two custom manufacturing tools, end to end. Both exist today as working lab prototypes. Taking one from a bench build to a robust, integrated, qualified piece of production equipment, including specification, component and supplier selection, build, debug, test.It’s an exciting full engineering problem in its own right, and it is yours to run. The Head of Technology and the contract manufacturing team will review the design as it develops, but the decisions will be yours to make.

Alongside that you will work on B.O.B itself as part of the R&D team: mechanical design in SolidWorks as the device heads for design freeze, hands-on V&V testing, and the documentation that goes with both. You will not be leading the regulatory submission but your work supports us build it.

Your first year will design freeze, transfer and equipment qualification. After that the device moves through submission and into manufacture, being the engineer who built the tooling and ran the testing you will then lead on this.

You will report to the Head of Technology and work day to day alongside them and the rest of the team. All work is carried out under our ISO 13485 quality management system.

What sets this role apart is that being a start-up creating a product to save lives you will have the ability to really make a difference whilst also having control of the full build.

What you will be doing

• Owning the development of one manufacturing tool: specification, component and supplier selection, build, debug and test through to formal qualification
• Building and running V&V tests hands-on, including benchtop rigs, fixtures, instrumentation and data capture. Helping to write protocols
• Analysis to support design decisions: hand calculation, FEA, tolerance stack-ups
• Supporting design transfer to our contract manufacturer
• Writing technical reports and design documentation which is fit for regulatory scrutiny

What we need from you

• A degree in mechanical engineering or a closely related discipline, or equivalent demonstrable experience
• Proven industry experience of mechanical design, from concepting to production of technical drawings for release to suppliers, and of developing test rigs, fixtures or production equipment and debugging them hands-on.
• Experience of using Solidworks or similar products.
• Enough comfort around electronics and software to specify, build and debug an instrumented test rig or a semi-automated machine. You will not be writing production firmware, but you will be the person who makes a tool work.
• Experience of regulated development or the desire to learn how regulated development works
• Excellent documentation skills coupled with the discipline to document your work properly and follow dual sign off processes.
• You will be driven as much by the R&D process as by the outcome and will find problem-solving itself as rewarding, as the finished product.
• Ability to work autonomously whilst working with a small team.
• Exposure to regulated product development, design controls or quality management systems such as ISO 13485.
• Experience taking a design through transfer to a contract manufacturer.
• Medical device experience or be prepared to undertake, formal QMS and regulatory training together with BSI training in ISO 13485 and in medical device manufacturing.
• Light and airily ground floor offices, just minutes from Cambridge’s main station.
• Opportunity to work on innovative, life-saving medical device solutions.
• Collaborative and supportive work environment.
• Competitive salary up to £60,000 depending on experience

ACT Medical is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

You must have the right to work in the UK, we are unable to provide sponsorship.