ABOUT NATUS

We’re the leading manufacturer of medical devices and software for a range of specialities, including new-born care, neurology, sleep, hearing and balance markets. Our mission is to improve patient outcomes in target markets through innovative screening, diagnostic and treatment solutions. Our Irish base in Gort, Co. Galway, manufacture and distribute a range of medical device products used in the diagnosis of human neurological disorders.
Are you a Manufacturing Engineer who has the demonstrated ability to successfully support busy production lines, with a hands-on approach and an aptitude for technical problem solving? We are looking for a passionate, self-driven individual who thrives in implementing new ideas and wants to join a forward thinking and growing company

EDUCATION AND/OR EXPERIENCE:

• Minimum Bachelor’s Degree in Electronics/Electrical Engineering or similar.

• Minimum of 3 years’ manufacturing engineering work experience in a heavily regulated industry, preferably medical device

• Must have: Exposure to validation process protocols in a heavily regulated environment
• Understanding of working and maintaining Product Design History File.
• Excellent organizational and interpersonal skills. You are proactive and a team player; you like to take ownership of projects and run with them.
• Demonstrate good approach to problem solving and project management.
• Experience with the application of statistical theories and methods to resolve production and engineering issues.
• Previous experience with direct production support would be an advantage.
• Strongly Preferred: Good working knowledge of regulatory expectations and industry practices including industry standards 21 CFR Part 820, ISO13485 and MDD.

• Prioritizes day to day activities to ensure full support to existing production processes.

• Gives technical guidance to production employee and associate engineers.

• Assist team in developing, and maintaining procedures, promoting good documentation practices, working on CAPA, complaint handling, internal audit, production and process controls and nonconforming product.
• Communicates regularly to management on progress for all work activities.
• Ensures that Production Lines are maintained in a validated state at all times.
• Develops and executes validation protocols (e.g. IQ, SV, TMV, MVP, MVR) in compliance with US and EU regulations.
• Contributes to developing project plans and budgets.
• Continually seeks to identify and drive improvements in process performance.
• Determine production methods to increase efficiency and reduce costs.
• Conceptualize tooling and manufacturing processes, estimate costs for process design, fabrication, and installations.
• Research, justify and propose capital equipment and/or processes investments
• Reviews and approves documents prepared by peers, sister sites or contractor (e.g. ECR, ECO, Validation report, Risk Assessments, PFMEA).
• Be a core team member of all manufacturing and distribution projects.

Travel Requirements: up to 15% domestic or international travel on a project need basis. Travel is likely to be 1 week per month for the first 9 months and will reduce after this.