Are you a Mechanical Engineer with experience of project management within a medical or In-Vitro Diagnostics device development?
Do you want to make a difference to the laboratory automation landscape by bringing an innovative product to the market?
Our client develops and manufactures game-changing laboratory automation equipment. This rapidly growing company is taking on a new challenge and adding a new product in automation of IVD applications to its pipeline.
You are an experienced senior Mechanical Engineer with a successful track record of multidisciplinary project management. With both technical and project management responsibilities and reporting directly to the CTO, you will be involved in managing, developing and delivering an early stage concept through to a CE-IVD marked product. You will work as part of an interactive team and help to shape the company’s future. This is an excellent opportunity to take a leading role in the development of a disruptive technology and have direct impact on the success and future of the company.
- Hands on Mechanical Development of a CE-IVD marked product.
- Project management of a multidisciplinary project, including: hardware, reagents and consumables.
- Supporting all phases of the product from development through to production and product lifecycle management.
- Working with the management team to define product strategy and future product requirements.
- Working with quality and regulatory personnel to ensure documentation and product compliance with the target directives.
- Bimonthly reporting to both CTO and CEO of project progress against forecast.
- Mitigation planning.
Requirements (all essential):
- Significant experience of hands-on managing technically challenging, multidisciplinary projects within a medical or IVD device development.
- Minimum degree qualified in Mechanical Engineering or similar.
- Track record of problem solving ability and taking development projects from seed through to launched product in medical or IVD applications.
- Ability, confidence and knowledge to understand and challenge the product development from first principles.
- Broad knowledge of mechanical, instrumentation and fluidic systems.
- High level of regulatory and quality understanding for development and launch of medical or IVD products, containing mechanical hardware, consumables and reagents.
- High level of injection moulding knowledge.
- Willingness for global travel.
For more information about this opportunity contact Keren on +44 (0)1279 657716 or email@example.com.
Job Ref: 9839
Senior Mechanical Engineer | Medical or IVD device development | to £65K