Engineering Design Manager (Medical Devices, ISO 13485, Research, R&D)
Our client is a fast-growing pioneering medical devices start-up with a patient-centric approach, which after more than 3 years of intense development and attention to user specifications, is preparing to introduce a range of quality products in neonatal care; with a focus on continual quality improvement and customer satisfaction.
The role offers the opportunity to lead the technical development of future products, a creative mix of designing and building products and project management to ensure the development of a range of world class products that will make a positive impact around the world and to play a key role in the growth of the company, building the development team.
The Technical Manager will lead and take ownership for the research and development of all products from concept to market, designing and building products, managing the team, 3rd party development partners and the overall product development programme.
Ideally a hands-on, self-starter who has previously led the design and development of a class 2 or 3 hardware medical device from concept to market. The Technical Manager will possess strong leadership skills as they will be building and leading the technical team around them as the company grows.
Duties and Responsibilities:
- Oversee each project’s life cycle from conception to completion, with an emphasis on technical soundness and resource efficiency within an ISO 13485 environment
- Liaise with internal and external stakeholders to refine and evaluate requirements, strategy and content needs for company products
- Be proficient in and design products using the latest CAD software, preferably Solidworks
- Build prototypes of devices to test functionality, usability and acceptability of new devices or features
- Create and manage documentation required for regulatory purposes including Technical Files / Design History Files (DHF), Verification and Validation data.
- Develop and revise project plans and statements of work, which should include accurate time and cost estimates
- Resourcing through directly hiring new team members and by engaging 3rd party development partners
- Assist in creating company policies and procedures relating to design and development
- Get involved in long-term business and financial planning at the executive level
- Maintain confidentiality and integrity when working.
- Previous experience of leading the development of a class 2 or 3 medical device from concept to market - ideally both in Europe (CE marking) and US (FDA).
- Experience developing products in conformity with the Medical Device Directive and working within a Quality Assurance driven environment ISO 13485 & ISO 14791
- Accomplished (preferably chartered) mechanical or design Engineer with strong knowledge of manufacturing tools and methods
- Excellent organisational and leadership abilities, a high level of initiative and ability to get on with things and make things happen is essential
- Proven project manager - ability to handle multiple projects through to completion on time and on budget, management qualifications e.g. PRINCE2 are preferable.
- Proven ability to build and lead a multi-disciplinary development team
- Previous experience of managing 3rd party/outsourced development partners and consultancies
- Great attention to detail and strong communication skills
- Excellent written and spoken English
- Medical Devices