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Medical Devices Design Lead

1 week ago

Queenstown, New Zealand Agency For Science, Technology And Research Full time

**About Us**

MedTech Catapult is a national initiative accelerating the development of high-value MedTech projects through an in-house product engineering unit. Our mission is to drive innovation and improve patient outcomes.

**Job Description**

We are seeking an experienced Medical Devices Design Lead to join our team. As a key member of our product engineering unit, you will be responsible for leading the design and development of complex medical technology products.

**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 PCBs 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 houses for electrical safety and medical device compliance.
  • To support the development of intellectual property portfolios 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.

**Requirements**

  • MSc/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, organized, and detailed.
  • Demonstrate strong interpersonal skills and leadership skills.

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