Our client is an exciting early-stage company based in Dublin whose mission is to revolutionize diagnostic medicine by providing immediate, accurate testing, in the near patient setting. We are looking to recruit an Engineering Manager to resource, plan, and execute engineering activities within assigned areas and the quality of the products produced. The Engineering Manager will be responsible for engineers internally and managing external resources.
- Reports to the Chief Operating Officer.
- Responsible for the ongoing design and development of the testing platforms.
- Responsible for the project management, monitoring and review of all internal and outsourced technical & functional activities relating to instrument development.
- Prepares and reviews of validation/calibration protocols and experimental data related to instrument development.
- Manages and develops intellectual property generated by development activities.
- Develops and maintains documentation relating to design, development, operation & validation of instrument development.
- Provide updates and reports on reader development for internal technical and management meetings.
- Responsible for managing the development process from concept generation through to design verification.
- Request quotes from suppliers for project specific materials or services.
- Apply new and existing technologies to provide the optimum instrument design.
- Ensures that all work complies with quality audit processes (e.g., ISO13485 and the FDA Quality System regulation, CFR Title 21 Part 820).
- Have technical contact with customers to optimise product design.
- Maintains product files and other relevant documentation to comply with quality standards.
- Provides training as appropriate to technical staff.
- Identifies and drives improvement opportunities.
- Hosts, or co-hosts, customer demonstrations.
- Prepares and reviews proposals, reports, and company documentation.
- Represents Company at trade shows and conferences.
- Co-ordinates and drives the authorship of scientific articles for publication and patent applications.
- Acts as member of Executive Management for Company eQMS.
- Acts as Functional Manager for Company.
- Other duties as defined by Company from time to time.
- Bachelor of Science degree in engineering, or a similar discipline is required.
- Master of Science degree in engineering or a similar discipline preferred.
- Previous experience developing and aligning departmental goals with overall business objectives is required.
- A minimum of 5 years of related experience in medical device development, or another FDA regulated industry.
- Expert in design controls and QMS process in an FDA regulated industry.
- Proven success of leading engineering teams in the delivery of medical devices in an FDA regulated environment.
- Must have excellent communication and interpersonal skills to communicate rapidly and effectively within the organization.
- Be a high energy, results-oriented leader with excellent collaboration and project management skills.
- Possess sound judgment and decision-making capabilities in research & development, technical, business, and regulatory compliance arenas.
- Effectively interface with Research and Development, Quality Assurance, and Regulatory Affairs business partners.
- Build a quality focused team with a strong culture and respect for each other. Ensure the teams understand their impact to the customer and patient health through innovation and input from staff.