Nine Twenty have been engaged by an exciting and forward thinking medical device and life sciences business based in Stirling.
This is an incredible opportunity to be involved in the whole project lifecycle from conception through design, test, validation, verification and manufacture. Working with cutting edge technology you have a chance to change and save lives whilst developing your experience working with Hi-Tech Electronic products and you will have the opportunity to interface with Quality Assurance, External Suppliers, Manufacturing and close customer Interface.
What's on offer for you?
Industry leading salary and benefits including 25 days paid holidays, in addition to public holidays, half day on Fridays, corporate gym and health suite membership and career development plans.
Qualifications/Experience
- Bachelor's degree in Electronics (preferred) or Mechanical Engineering with a proven track record in an engineered product environment, and with an understanding of Engineering Principles and Design Practices.
- Minimum of 5 years' experience in product development of hi-tech electronic products or systems, across the full product lifecycle.
- Experience of working within the Medical Devices (preferred) or life sciences sectors is highly preferred. Working knowledge of regulatory requirements, particularly ISO 13485 is an advantage.
- Demonstrable multi-disciplinary and practical hands-on engineering approach, with a systems electronics background.
Skills Required:
- High standard of communication and written skills required.
- Ability to analyse circuits at system level from schematics and Test (oscilloscope etc).
- Confident and comfortable in customer communications, and in any size of group meetings.
- As signoff authority, experience with specifying and analysing technical drawings is required.
- Competent computer skills and attention to detail.
- Ability to create ideas and develop solutions; excellent problem-solving skills.
- Leadership and team working skills.
- Ability to travel when required; infrequent.
Desirable:
- Experience with 3D modelling software is an advantage, Solidworks preferred.
- Experience with electronics schematic packages is desirable.
- Experience in working with programmable devices (pSoC, FPGA) is an advantage.
Position Summary
(Key Tasks)
Product Development
- Developing and qualifying medical device systems and products incorporating advanced microwave technology, in accordance with the Company's design control procedures and quality standards.
- Design and development of the product, including but not limited to aesthetic design, user interaction design, design for manufacture.
- Management of project work packages, for example in managing the project risk file or reliability plan.
- Leading electronics debug activities from schematic analysis and Test with support from electronics design engineers. Creation of test jigs, including the use of LabView or similar.
- Carrying out verification and validation activities to agreed schedules, quality and cost.
- Working with and managing suppliers, subcontractors, and other engineering disciplines.
- Generating design documentation in compliance with the Company's design control procedures.
- Generating manufacturing documentation in compliance with quality standards.
Research
- Supporting the R&D department in developing and assisting in the feasibility of new concepts, in alignment with the requirements of the Company’s Research strategy.
- Quality Assurance and Project Management
- Assisting in the development of medical systems in accordance with the Company’s standard operating procedures and in compliance with ISO 13485 and QSR; and ISO9001.
- Assisting in the management of outsourced projects including all suppliers, subcontractors, quality, regulatory and manufacturing/printing.
Marketing
- Supporting the R&D department through occasionally performing literature searches and précis on proposed development with feasibility analysis on new product concepts;
- Assisting with technical writing of manuals and other company literature and, when appropriate, author peer reviewed papers for publication in journals and presentations at conferences and trade exhibitions;
Production
- As part of a project team, conducting product Transfer To Manufacturing to subcontractor manufacturing sites.
- Generation of manufacture documentation in compliance with relevant standards.
- Implementation of best practice manufacturing techniques for one-off designs to high volume production, assembly processes, and material selection.
- Ongoing technical support for manufacturing where required.