Sustaining Engineer

Ireland - Gort (Neuro), IDA Business Park, Gort, Galway, IrelandJob DescriptionPosted Tuesday, September 2, **** at 7:00 AMOverviewFOR MORE THAN 80 YEARS,Natus has been working in collaboration with clinicians to deliver industry-leading neuro solutions that help providers more easily make sense of the body's signals.Engineered with input from those who have lived the care experience, our technology simplifies complex processes and improves accuracy and efficiency.There is a role for everyone who wants to be part of the innovative solutions atNatus Neuro.Job Function: EngineeringJob Family: Hardware EngineeringRole and ResponsibilitiesThe Sustaining Engineerwill lead product sustaining engineering and continuous improvement efforts, as well as providing key voice-of-manufacturing and voice-of-customer feedback to guide new product designs, in the maintenance and sustainment of the Natus' Neuro product portfolio.The candidate will be the focal person for all technical and product sustaining issues in manufacturing, depot and field service, and for providing project management and technical leadership for changes, enhancements, and extensions of existing products.This role will provide technical leadership in support of resolving product and manufacturing site issues.The successful candidate must be highly organized with prior experience in manufacturing sustaining roles including cross-discipline knowledge of mechanical, electrical, systems, and test engineering, and will use these strengths to help drive issue resolution in collaboration with cross-function teams.This candidate must also be able to succeed in an entrepreneurial environment and not be hindered by ambiguity or competing priorities.Travel: up to 15% domestic or international travel on an as needed basis.What you'll get to do in this roleServe as the next-level of technical support for all product design-related matters related to released manufactured products and purchased components.Lead efforts to perform root cause analyses, resolve issues, implement product and manufacturing process changes, modifications, and design enhancements.Investigate and resolve corrective and preventative actions using appropriate problem-solving techniques (DMAIC, FMEA, Ishikawa, 5-Whys, etc.).Track product issues, drive effective and swift resolution, and monitor metrics associated with the team's work.Support the implementation and maintenance of processes utilized in internal and external manufacturing, and depot repair and field service activities.Prevent and/or respond to production stoppages due to supplier, process, or quality related matters.Drive continuous improvement and Value Engineering initiatives on released product.Lead team efforts aimed toward improving customer satisfaction, product quality improvement, manufacturing yield improvement, reducing product variability, and reducing the cost of goods sold.Provide engineering support for component obsolescence issues.Provide engineering support for product compliance and safety (IEC *****, REACH, ROHS, CE, etc.).Support change management across Natus Neuro's product lines, including drafting and coordinating the implementation of Engineering Change Orders.Support the design and testing of new products via effective Design for Manufacturing feedback.Deliver medical device design documentation compliant with FDA design controls, good documentation practices, ISO ****, and ISO *****.Maintain medical device Design History Files and Device Master Records.Support the development, change, and release of design documentation according to the Natus Quality Management System, including design artifacts such as BOMs, drawings, pFMEAs, dFMEAs, work instructions, and manufacturing procedures.What we are looking forBachelor's degree (B.S.) from an accredited, four-year university or college in electrical, mechanical, systems, manufacturing, biomedical engineering, or similar degree.4+ years of sustaining/process engineering experience, preferably in the medical device industry manufacturing electro-mechanical products.Strong project management and organizational skills.Self-starter must be able to work independently with minimum supervision or direction in a global environment.Must have a strong work ethic and ability to communicate effectively, both verbally and in writing.Ability to work with electronics, PCs and operating systems (understanding and proficiency), and MS Office applications including MS Project.Ability to read schematics and other electrical/electronic engineering documentation.Desirable experience or skillsets (not required)Lean Six Sigma Black Belt or Green Belt;Knowledge of SMT manufacturing processes;Experience with LabView or other test software language/platforms;Knowledge of regulatory requirements in medical device industry;Experience in FDA Quality System Regulations, Current Good Manufacturing Practices, risk management (ISO *****), and Quality Management Systems for Medical Devices (ISO *****);Experience in human factors engineering and usability engineering for medical devices (IEC *********, IEC *****, ANSI/AAMI HE75) and medical device safety standards (IEC *****).Compensation and Benefits:Along with a competitive salary and bonus structure, we offer a comprehensive benefit package to start: Health & Life Assurance cover, defined contribution pension plan, active sports and social club, flexible work location, flextime (depending on position), excellent career progression opportunities, free parking, and educational assistance.Be the Peoplepart of the Neuro Solution.Apply Today.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.#J-*****-Ljbffr