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Job Description
Aerogen seeks a Principal Electronic Engineer to design and develop medical devices in line with CE & FDA regulations, collaborating with cross-functional project teams to improve patient lives worldwide.
About Aerogen
Aerogen is a world leader in acute care aerosol drug delivery, headquartered in Galway with offices globally. Our employees make a difference in patients' lives every day, reaching 20 million patients in over 80 countries.
Job Description
The Principal Electronic Engineer will design and develop medical devices in line with CE & FDA regulations, collaborating with cross-functional project teams to improve patient lives worldwide.
Key Responsibilities
- Leadership:
- Manage direct reports, assign goals, and ensure accountability within the team.
- Maintain and enhance engagement and positive culture within the team and organization.
- Conduct performance reviews, provide feedback, and identify growth opportunities for junior team members.
- Mentor and support team members in their career development.
- Task Management:
- Oversee the hardware development lifecycle, from concept to production.
- Ensure projects are completed on time, within scope, and within budget.
- Define project scope, goals, and deliverables.
- Coordinate with project managers, embedded software engineers, and other stakeholders to align project goals and deliverables.
- Planning and assignment of work tasks.
- Providing technical support to manufacturing for sustaining production.
- Apply failure analysis skills to determine and document root cause of product system or component failure.
- Strategic Planning:
- Align engineering goals with organizational objectives.
- Resource allocation and budgeting.
- Technical Expertise:
- Develop and maintain electronic hardware, ensuring compliance with industry standards and regulations.
- Direct the design and implementation of the hardware deliverables.
- Resolve hardware issues.
- Quality and Regulatory Compliance:
- Ensure all hardware development activities adhere to medical device regulations and standards.
- Conduct hardware design and documentation reviews, delivering high-quality hardware deliverables.
- Shared ownership of hardware development processes and maintaining them to current standards and best practice.
- Innovation and Continuous Improvement:
- Stay up to date with advancements in electronic hardware design, medical device technology, and relevant standards and guidance documents.
- Identify and implement best practices, tools, and methodologies to enhance development efficiency and product performance.
- Drive continuous improvement initiatives within the team.
- Complete documentation for intellectual property filings, freedom to operate, literature reviews, R&D tax credit applications, and grant applications.
- Collaboration:
- Collaborate within R&D, Manufacturing, Operations, QA/RA, Commercial, and Marketing functions as necessary.
- Communicate regular and accurate updates on project deliverables, including any risk of divergence from the plan to the project manager and/or management.
- User Engagement:
- Engage with clinicians and users in their environment to elicit user needs/functional requirements.
Requirements
- BEng or equivalent in Electronic Engineering.
- Minimum 9 years hardware design experience, preferably in the medical device industry.
Key Skills
- Proficient in electronic circuit design, analog, and digital.
- Experience in creating hardware deliverables required for medical electrical device development.
- In-depth understanding of the following standard and guidance documents for the development of hardware for medical device design:
- IEC/EN 60601 Series for Medical Electrical Equipment
- FDA Guidance Documentation
- Knowledge of embedded software design as it relates to hardware design.
- Experience of hardware validation for medical electrical equipment.
- Support of medical electrical equipment manufacturing from prototype to production and sustaining of same.
- Experience using development tools such as Or CAD Capture and PCB Designer.
- Experience of Microcontroller interfacing such as SPI, I2 C, UART, ADCs, etc.
- Familiar with the interfacing of wireless comms modules (Bluetooth, Cellular, etc.).
- Technical input and review of related project documentation.
- Effective verbal and written communication skills.
- Ability to convey technical concepts to non-technical stakeholders.
- Strong interpersonal skills with the ability to collaborate cross-functionally.
- High level of accuracy and attention to detail.
- Self-directed with effective time-management skills and willingness to learn new skills and adapt to meet current challenges.
- Openness to continuous learning and improvement.
- Flair for innovation.
- Commitment to maintaining high ethical and professional standards.
- Ability to document engineering evolution, development, and testing.
About Working at Aerogen
Aerogen is committed to promoting diversity, inclusion, and equality in the workplace. We understand that your life evolves through different stages, and we are here to support our global team with a range of financial and non-financial rewards and benefits.