QUALIFICATIONS / SKILLS / ATTRIBUTES:

• Degree in Electrical or Electronic Engineering or similar discipline, with 3+ years’ medical device industry experience in a product development or manufacturing role.
• Have fundamental electronics knowledge with experience in both digital and low-noise analog circuits.
• Experience with programming languages C and C++ and embedded hardware fundamentals related to use with Microcontrollers and popular interfaces such as Bluetooth, UART etc.
• Experience in liaising with PCB fabricators and PCBA vendors, including a basic knowledge and understanding of relevant IPC standards for surface mount technology (SMT).
• PC Literate (word processing, spreadsheets, data base) and a good knowledge of project Management tools.
• A good understanding of quality management system principles (e.g. ISO 9001 or ISO 13485) and/or FDA quality system regulation processes according to 21 CFR part 820 and EU MDR.
• A team player with excellent interpersonal and communications skills, with the ability to solve problems ad-hoc and self-motivated.
• Experience in the development of test methods and associated product testing.
• Excellent analytical skills, ability to plan, organise and implement multiple concurrent tasks.
• Ability to present ideas and concepts clearly and effectively to all levels of the company.
• Excellent planning and coordination skills and capable of initiating and leading change.
• Experience and/or knowledge of risk management techniques, e.g. FMEA and/or ISO 14971.
• Experience in Design for Test (DFT) and Design for Manufacture (DFM).

DESIRABLE SKILLS AND KNOWLEDGE:

• Relevant experience in the medical device, electro-acoustic or another highly regulated industry is preferable.
• Strong attention to detail and commitment to quality.
• Strong analytical problem-solving skills and able to make efficient decisions.
• Continuous improvement mindset & understanding of Lean principles.
• Experience in design and testing for electromagnetic compatibility (EMC), e.g. to the Radio Equipment Directive, Federal Communications Commission (FCC) or other EMC standards.
• Knowledge and understanding of international safety standards such as IEC 60601, IEC 69050 or IEC 60065.
• Experience in the development of test methods and product testing.
• Experience in the application of statistical principles and the use of statistical software such as R, STATA or Matlab.
• Ability to work effectively under pressure in a fast paced environment to ensure assigned projects and tasks meet required deadlines.
• Willingness to travel internationally as required.

ABOUT THE ROLE:

The company is seeking to expand its engineering department to work on hardware development for current and new medical device products that combine neuromodulation, wireless communications and physiological sensing technologies and to support ongoing product design validation and production process validation activities.
The company provides its engineers with a dynamic working environment and opportunities to work on a variety of development, commercial and research projects as part of a motivated, cross-functional team. The successful candidate will gain exposure to a range of technologies at the forefront of biomedical research and every phase of the product development lifecycle from initial concept work through to commercial release.
Reporting to: VP of Global Operations

KEY RESPONSIBILITIES:

• Work closely with the Product Development Team to design, develop, build and test current and next generation medical devices.
• Support product development from concept generation through to post-production.
• Participate in prototyping of circuits, including liaising with prototyping service providers.
• Participate in product testing, including electromagnetic compatibility (EMC), wireless coexistence, safety, reliability validation and performance testing.
• Support design and technology transfer from product development to manufacturing by proactively working with stakeholders from manufacturing and quality.
• Provide support to Manufacturing to facilitate efficient operations within the production, to optimise existing processes and to ensure that production goals are met.
• Support the design, development and validation of custom printed circuit board assembly (PCBA) test equipment for Neuromod’s products.
• Oversee the analysis of hardware failures from the field and participate in associated corrective and preventive actions.
• Perform necessary design activities through utilization of CAD software such as Spice, Altium and Matlab.
• Analyse and solve problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems.