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Lead Engineer
1 week ago
MedTech Catapult is a national initiative for accelerating the development of high-value MedTech projects through an in-house product engineering unit.
This productization unit is responsible for supporting the development of technologies through the medical device development cycle to produce full-fledged hardware product systems.
The Lead Engineer will report to the Lead, Product Engineering.Job Responsibilities:To provide electronics and instrumentation design capability in support of the design, development, test and manufacture of safety critical products and processes for complex medical technology product solutions.To interact closely with engineers from other disciplines to achieve an optimized design within the stipulated project schedule.To design and develop PCB and control systems for next generation medical devices.To provide operational electronics development, prototype design and testing - both analogue and digital.To conduct PCB schematic capture and layout, including component selection and testing.To build and test prototypes and document the design and performance of these.To create embedded system design and implementation.To conduct EMC testing with in-house equipment and through liaison with EMC test house for electrical safety and medical device compliance.To support development of intellectual property portfolio in device design and process technology know-how.To provide clearly documented records of technical data, decisions, methodologies, calculations and software use in accordance with ISO/FDA quality standards.To support the Procurement and Engineering teams for sourcing and defining specifications.To conduct error and tolerance sensitivity analysis, reliability analysis, reliability testing and reliability test program design.To support CAD-based electro-mechanical integration, at the component level, board level and assembly level.Write and review documentations for QMS.Interface with external parties (design houses) to communicate product requirements.To support other activities for product engineering when required.RequirementsMSc/BSc in Electrical Engineering or Computer Engineering.>10 years experience in medical devices (e.g.
electronic product design).Has a good knowledge and understanding of i) Processes of electronic product development and realization, ii) operation and design of electronic systems and circuits; iii) Regulations applying to medical devices, iv) Electronic device operation and fabrication and v) Electronic sensors, measurement systems and instrumentation.Experience with PCB design ?
digital and analogue.Proficient in HDL languages (Verilog, System Verilog).Knowledge of ASIC design and sign-off.Familiarity with scripting languages like Python, Perl, or C/C++ is a plus.Experience with design, development or manufacture of photonic systems or photonics-enabled products is a plus.Experience with the use of simulation tools for electronic design is a plus.Experience with Medical device ISO standards including ISO9001, IS013485, ISO 14971 and IEC 60601-1 and managing QMS.Good collaboration skills, organised and detailed.Demonstrate strong interpersonal skills and leadership skill.
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