<p>Senior Sustaining Engineer- Med Device Middleton, WI (In-Person Role) We welcome applicants from outside the area, and relocation support may be provided for exceptional candidates.</p> <p>The Senior Sustaining Engineer is a crucial team member who will lead product sustaining engineering leadership, provide key voice-of-manufacturing and voice-of-customer feedback to guide new product designs, and drive continuous improvement efforts in the maintenance and sustainment of the entire Natus' Neuro medical device portfolio. This engineer 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 current products. This role will provide technical leadership and mentoring to the greater Sustaining Engineering team and act as a technical consultant to support medical device issues and our network of stakeholders. The successful candidate must be highly organized with prior experience in manufacturing sustaining roles including robust knowledge of mechanical, electrical, systems, and test engineering, and will use these strengths to help drive swift 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. This role is heavily slanted toward product sustaining- dealing with everything that arises over the many years of manufacturing and maintaining a product such as component obsolescence, design changes required to improve performance, aesthetics, and marketability, quality concerns (yield improvement), product cost improvement, and field issue investigations. This type of engineer will be required to often change the product design to meet the new need- including mechanical and electrical changes What you'll get to do in this role:</p> <p>Serve as the highest level of sustaining engineering 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 technical issues via corrective and preventative actions- leveraging appropriate problem-solving techniques (DMAIC, FMEA, Ishikawa, 5-Why, 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. 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 testing (IEC 60601, REACH, ROHS, CE, etc.). Support engineering 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 by providing effective Design for Manufacturing / Design for Test guidance. Deliver medical device design documentation compliant with FDA design controls, good documentation practices, ISO 9001, and ISO 13485. 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, and manufacturing procedures.</p> <p>What we are looking for: Basic qualifications</p> <p>Bachelor's degree (B.S.) from an accredited, four-year university or college in electrical, mechanical, systems, or biomedical engineering, or similar degree. 5+ years of sustaining engineering experience is required, preferably in the medical device industry Ability to work with electronics, PCs and operating systems (understanding and proficiency), and MS Office applications including MS Project Strong project management and organizational skills. Ability to read electrical engineering documentation including schematics.</p> <p>Desirable Skills:</p> <p>Lean Six Sigma Black Belt or Green Belt Knowledge of SMT manufacturing processes Experience with developing PCB schematics and layout design Experience with LabView or other test software language/platform Knowledge of regulatory requirements in medical device industry Experience in FDA Quality System Regulations, Current Good Manufacturing Practices, risk management (ISO 14971], and Quality Management Systems for Medical Devices [ISO 13485] Experience in human factors engineering and usability engineering for medical devices [IEC 60606-1-6, IEC 62366, ANSI/AAMI HE75] and medical device safety standards [IEC 60601] Experience with Agile PLM</p> <p>Travel Required: 10% domestic and/or international travel on an as needed basis</p>