Job Description: Senior Mechanical Engineer

Company Profile
Neuromod Devices Ltd. (“Neuromod”) is a venture-backed Irish medical device developer of a neuromodulation-based treatment of tinnitus, a debilitating condition commonly known as ‘ringing in the ears’. Tinnitus constitutes a significant unmet clinical need, affecting up to 1% of the global population and for which there are no proven effective treatments.

We are now seeking to expand our engineering department to work on software and 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 commercial and research projects as part of a small, 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.

Key responsibilities

  • Work closely with project Lead and Product Development team to develop, build and test next generation medical devices.

  • Support product development from concept generation through to post-production.

  • Manage and update specifications/drawings and initiate ECO’s in support of Sustaining

  • Engineering and Operational needs.

  • Support design and technology transfer from product development to manufacturing by

  • proactively working with stakeholders from manufacturing and quality.

  • Liaise with Manufacturing Team and external suppliers on an ongoing basis during the

  • development stages to guide Design for Manufacturability activities.

  • Oversee the analysis of hardware failures from the field and participate in associated corrective and preventive actions.

  • Participation in the drafting of test protocols may be required, in addition to documenting test results and generating test reports. Testing may include mechanical, electrical, performance, user interface / usability and software.

  • Perform necessary design activities through utilization of 3D and 2D CAD software.

  • Analyse and solve problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems.

  • Report writing and preparing presentations to communicate findings.

  • Provide coaching and mentorship to other members of the Engineering Team

Qualifications / Skills / Attributes:

  • Degree in Mechanical Engineering, Manufacturing Engineering or similar discipline with 5+ years' medical device industry experience in a product development or manufacturing role.

  • Product design and development experience, including experience in design review, risk management and quality procedures.

  • Proficient in using Solid Works, Inventor or equivalent 3D CAD design package.

  • 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.

  • 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.

Desirable skills and knowledge:

  • Relevant experience in the medical 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 & experience of Lean principles.

  • Proven track record for identifying and implementing improvements to processes and mitigate risk.

  • Knowledge and understanding of international safety standards such as IEC 60601, ISO 14971 and ISO 10993.

  • 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.

  • Ability to work effectively under pressure in a fast paced environment.

  • Willingness to travel internationally as required.

For further information please contact Aoife McNally