Senior Electronic Engineer
We are now seeking to expand our 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.
We provide our 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: Director of Operations
• Support product development from concept generation through to post-production.
• 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 area, to optimise existing processes and to ensure that production goals are met.
• Oversee the analysis of hardware failures from the field and participate in associated corrective and preventive actions.
• Work closely with the Product Development Team to design, develop, build and test current and next generation medical devices.
• Support the design, development and validation of custom printed circuit board assembly (PCBA) test equipment for Neuromod’s products.
• Perform necessary design activities through utilization of CAD software such as Spice, Altium and Matlab.
• 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.
• Analyse and solve problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems.
• Qualifications / Skills / Attributes:
• Degree in Electrical or Electronic Engineering with 5+ years' medical device industry experience in a product development or manufacturing role.
• Have a fundamental electronics knowledge with experience in both digital and low-noise analog circuits
• Experience in liaising with PCB fabricators and PCBA vendors, including a basic knowledge and understanding of relevant IPC standards for surface mount technology (SMT).
• An understanding of quality management system principles (e.g. ISO 9001 or ISO 13485) and/or FDA design and development processes to 21 CFR part 820.
• 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).
• Good knowledge of standard PC applications (word processing, spreadsheets, data base) and project management tools.
• A team player with excellent interpersonal and communications skills, with the ability to solve problems ad-hoc.
• Ability to present ideas and concepts clearly and effectively to all levels of the company.
Desirable skills and knowledge:
• Relevant experience in hearing or electro-acoustic industry is preferable.
• 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 schematic capture and PCB layout (RF design experience is not essential).
• Experience in the development of test methods and associated product testing.
• Experience in the application of statistical principles within an engineering discipline, with experience in the use of statistical software such as R, STATA or Matlab.