Location: Gort, Co. Galway (Onsite)
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, manufactures and distributes 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.
“The success of our company depends on our employees. This is where you come in”
Essential Duties & Responsibilities:
1. Prioritizes day to day activities to ensure full support to existing production processes.
2. Gives technical guidance to production employees and associate engineers.
3. Assists team in developing and maintaining procedures, promoting good documentation practices, working on CAPA, complaint handling, internal audit, production and process controls, and nonconforming product.
4. Communicates regularly to management on progress for all work activities.
5. Ensures that Production Lines are maintained in a validated state at all times.
6. Develops and executes validation protocols (e.g. IQ, SV, TMV, MVP, MVR) in compliance with US and EU regulations.
7. Contributes to developing project plans and budgets.
8. Continually seeks to identify and drive improvements in process performance.
9. Determines production methods to increase efficiency and reduce costs.
10. Conceptualizes tooling and manufacturing processes, estimates costs for process design, fabrication, and installations.
11. Researches, justifies, and proposes capital equipment and/or process investments.
12. Reviews and approves documents prepared by peers, sister sites, or contractors (e.g. ECR, ECO, Validation report, Risk Assessments, PFMEA).
13. 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.
Education and/or Experience:
1. Minimum Bachelor's Degree in Electronics/Electrical Engineering or similar.
2. Minimum of 3 years' manufacturing engineering work experience in a heavily regulated industry, preferably medical device.
3. Must have: Exposure to validation process protocols in a heavily regulated environment.
4. Understanding of working and maintaining Product Design History File.
5. Excellent organizational and interpersonal skills. You are proactive and a team player; you like to take ownership of projects and run with them.
6. Demonstrate a good approach to problem solving and project management.
7. Experience with the application of statistical theories and methods to resolve production and engineering issues.
8. Previous experience with direct production support would be an advantage.
9. Strongly Preferred: Good working knowledge of regulatory expectations and industry practices including industry standards 21 CFR Part 820, ISO13485 and MDD.
Benefits
1. Attractive salary package.
2. Health Insurance & Life Assurance cover.
3. Company Pension.
4. Educational assistance.
5. Flexi time.
6. Employee Recognition and Rewards.
Natus Medical Incorporated is recognized by healthcare providers globally as the source for solutions to screen, diagnose and treat disorders of the brain, neural pathways and sensory nervous system. Our vision is to deliver innovative and trusted solutions to advance the standard of care and improve patient outcomes and quality of life. Natus products are used in hospitals, clinics, and laboratories worldwide.
EEO Statement: Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.
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