Stop the press!! Calling all Electronics Engineers who enjoy working across the full product lifecycle - from product concept through to manufacturing support. Working alongside and complementing existing analogue and digital design capability
The Electronics Engineer role is perfect for an innovative, hands-on self-starter who would like to work as part of a driven and supportive team which designs and manufactures novel medical device products to improve the world around us!
The role is ideally suited to an individual with analogue design skills and experience who can support new product development activities, maintenance of the existing healthcare product range, and development of test fixtures and equipment.
Reporting to the Principal Hardware Engineer, the Electronics Engineer will be the lead analogue design authority within the organisation. The Electronics Engineer will initially be responsible for analogue design, schematic and PCB layout activities on an innovative new medical treatment platform, including support for specification, verification & validation, reliability, and risk management activities.
As a medical devices company, certified to ISO 13485, accuracy of documentation is essential throughout product design and maintenance. This includes a thorough systems engineering approach to documenting requirements, verification/validation activities, and with consideration of quality and risk management throughout.
Your deliverables will include the following:
Product Development
Design, Development, and qualification of new medical device products in accordance with the Company's design control procedures and quality standards (including ISO 13485 and QSR).
Defining and carrying out verification and validation activities to agreed schedules, quality, and cost.
Employing best practice design and development techniques including (where applicable) simulation, design for manufacture, design for test, reliability analysis and single fault analysis.
Planning, defining and development of equipment and jigs to support verification and production.
Working with and managing suppliers, subcontractors, and other engineering disciplines.
Requirements management activities.
Creation of Customer Facing documentation including instructions for Use and User Manual Documents.
Supporting the existing product range through upgrades resulting from regulatory changes or customer requests, in accordance with change control procedures.
Quality Assurance
Completion of Non-Conforming Product (NCPs) or Corrective and Preventative Action investigations (CAPAs) as required by the Company's quality standards.
Providing technical support for customer returns or complaints.
Providing technical support for QA investigations.
Operations
Supporting Operations through management of product Transfer To Manufacturing; project handover.
Definition and generation of manufacturing documentation (e.g. test and calibration procedures) in compliance with quality standards.
Supporting the 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 including debug activities and process improvements.
Marketing / Research
Supporting Marketing & Research through technical contribution to feasibility analysis and bid development on proposed new projects or product developments.
What you’ll need to succeed
You will be an energetic, passionate, self-starter with a positive disposition and someone who will relish a working environment which is focussed on growth and the changes needed to deliver it.
Some of the key skills you’ll bring are:
- Bachelor's degree in Electronics Engineering (or similar).
- Electronics schematic and layout design experience (ideally in Altium Designer) for analogue and digital circuits, with a design focus weighted towards analogue design.
- Proficient in electronics circuit simulation (SPICE, Power Distribution, High Speed Signal Integrity).
- As signoff authority, confident in specifying and analysing technical drawings.
- Proficient user of electronics Test & Measurement equipment.
- Skilled in preventative design for first time pass at Electromagnetic Compatibility (EMC) and Immunity (EMI) testing.
- Skilled in reliability analysis (worst case circuit analysis, component de-rating) and design for safety critical applications (electrical safety, single fault analysis).
- High attention to detail and methodical approach to ensure requirements are comprehensively met.
- High standard of communication and written skills.
- Working knowledge of product change management (Engineering change orders).
- Confidence in creation of specifications, test plans and reports.
- Familiarity with process risk management, e.g. FMEAs. Knowledge of product risk management to ISO 14971 would be beneficial.
- Teamwork skills and ability to create ideas and develop solutions.
- Experience in interfacing with manufacturing facilities, suppliers or design subcontractors would be beneficial.
- Confident and comfortable in customer communications, and in any size of group meetings.
- Desirable: Experience in low power consumption design including battery supply charging circuits, thermal and safety management.
- Desirable: Experience in design related to communication protocols including USB, Ethernet, CAN, I2C, SPI, RS232, RS485, Bluetooth Low Energy
- Desirable: Experience in FPGA design (using VHDL), in a supporting capacity to dedicated design resources.
- Desirable: Experience in embedded software design, in a supporting capacity to dedicated design resources.
- Desirable: Experience in test software design for equipment interfacing, e.g. LabVIEW.
- Desirable: Knowledge of medical devices standards, particularly ISO 13485 and IEC 60601.
- Desirable: Experience of working within the medical devices sector or a similar highly regulated sector.
- Driving license and ability for infrequent travel, primarily to local CEM partner.
What you’ll get in return
· Salary: TBD.
· Pension: 3% Employers contribution.
· Annual Leave Allowance: 33 days (including bank holidays)
· Bright, modern work environment with a focus upon employee wellness. A planned move during 2023 to a custom designed facility in Stirling, with excellent commuting links and which includes an employee gym and wellness suite.