Electronic Design Engineer with experience in the design of Medical Devices required by high-growth medical devices company in Galway.
From it’s headquarters in Galway, my client designs highly sophisticated life-saving medical devices. Due to expansion in global markets, they are growing their design team yet again.
Collaborating with a cross-functional team, you will conduct product design and development in accordance with CE & FDA regulations for medical device design and manufacture for global markets.
Requirements:
- Degree in Electronic Engineering / similar
- 4+ years experience in an Electronic design role
- Proficient in electronic circuit design – analog and digital
- Experience using development tools such as OrCAD Capture and PCB Designer
- Knowledge of Microcontroller interfacing such as SPI, I2C, UART, ADCs etc.
- Strong interpersonal skills with the ability to collaborate in a multi-disciplinary team
- Self-directed with effective time-management skills
- Flair for innovation
- Ability to document engineering evolution, development, testing, and reporting using MS Office applications such as Word, Excel, PowerPoint etc.
Responsibilities:
- Collaborate as a member of cross-functional project teams in developing products from concept through to commercialization
- Conduct product design and development in accordance with CE & FDA regulations relating to medical device design and manufacture
- Conduct product design in accordance with the project objectives with due consideration of project schedule, budget, risks, regulatory submission, standard compliance
- Conduct use and design risk assessment, implementing controls or mitigations to reduce risk levels
- Conduct and record proof of principle testing of prototypes to confirm feasibility of ideas and concepts
- Engage with clinicians and product users in their clinical setting to elicit user need/functional requirements
- Prepare technical documentation in clear and concise terms in accordance with good engineering practice
- Participate in technical design reviews to ensure electrical design integrity and safety are achieved
- Apply failure analysis skills to determine and document root cause of product system or component failure
- Conduct assessment of the competitive IP landscape, including freedom to operate and literature review
- Prepare invention disclosures and patent applications to ensure protection of intellectual property
- Maintain current and accurate records of the iterative design process, trial and error and experimental steps to support the design history file and for R&D grant and tax credit submissions
- Liaise closely within R&D, Science, Manufacturing, Operations, Quality, Sales and Marketing functions through the product development lifecycle
- Maintain current working knowledge of the key international standards, regulations and regulatory guidance direction that govern the medical devices industry including medical electrical equipment
- Communicate regular and accurate updates on project deliverables including any risk of divergence from the plan to the project leader and/or management
- Maintain and enhance engagement and positive culture within the team and organization
- Demonstrates and models through leadership style and behavior, respect for company core values and a commitment to teamwork
- Technical input and review of related project documentation
- Prepare invention disclosures and patent fillings as appropriate
- Support of medical electrical equipment manufacturing from prototype to production and sustaining of same
Benefits:
- Excellent career opportunities
- Competitive salary
- Health Insurance
- Dental Insurance
- Permanent Health Insurance
- Pension scheme
- Bonus
- Flexitime
- Death in Service Benefit
- On-site car parking
Please send CV in confidence to emer@emtechrecruitment.ie
emer@emtechrecruitment.ie
