NATUS MEDICAL Senior Electrical Engineer in MIDDLETON, Wisconsin

JOB REQUIREMENTS: Senior Electrical Engineer Requisition ID: 8074 Location: USA, Wisconsin, Middleton Employment Duration: Regular Full time Description Natus Medical Inc. is looking for a Senior Electrical Engineer to join our Team in Middleton, Wisconsin. Founded in 1989, Natus Medical Incorporated is a leading manufacturer of medical devices and software and a service provider for the Newborn Care, Neurology, Sleep, Hearing and Balance markets. Natus products are used in hospitals, clinics and laboratories worldwide. Our mission is to improve outcomes and patient care in target markets through innovative screening, diagnostic and treatment solutions. Job Summary: An Electrical or Biomedical Engineer Designs, develops, modifies and evaluates components and processes used in the generation, manipulation, transmission and storage of electricity. Determines design approaches and parameters. Analyzes equipment to establish operating data, conducts experimental tests and evaluates results. Selects components and equipment based on analysis of specifications and reliability. Completes documentation and procedures for installation and maintenance. May interact with users to define system requirements and/or necessary modifications. In this job, you will: Establish first line of technical support for all design related matters occurring on released manufactured products and purchased components. Contribute as key member of the cross functional Product Quality Teams. Prevent and/or respond to production stoppages due to supplier, design or quality related matters. Perform electrical, or electronic design maintenance due to component obsolescence or value engineering proposals to include testing and validation as required. Review, qualify and document sourcing changes on all components. Support the service depot for product design quality issues and the maintenance of service parts kits as defined by Customer Service Department. Assist by providing guidance for the technical content of technical service bulletins. Write and coordinate the implementation of engineering change orders. Implement computer and computer peripheral changes in BOMs. Drive continuous improvement and Value Engineering initiatives on released hardware products. Process any new marketing configuration requests when it incorporates existing released components and assemblies. Update Construction Data Reports when driven by self-originated design changes. Coordinate with Regulatory and Agency authorities to ensure product compliance with safety standards and product efficacy. Assist when follow up testing is required. Serve as a liaison between Software engineering and Manufacturing to facilitate the implementation of software changes. Serve as point of contact for Construction Data report Audits. Follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers. Deliver medical device design documentation compliant with FDA design controls and good documentation practices. Create and maintain medical device Design History Files and Device Master Records. Identify potential medical device hazards and maintains Risk Management files. Conduct medical device safety testing and maintains product compliance with applicable UL, ISO, and IEC 60601 standards as well as international regulatory requirements. Investigate and resolve corrective and preventative actions using appropriate problem solving techniques (DMAIC, FMEA, Ishikawa, etc.) Assist with other engineering work as required. Travel up to 25%, domestic and/or international. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability. ***** OTHER EXPERIENCE AND QUALIFICATIONS: Minimum 8 years of applicable work experience, preferably in the medical device industry manufacturing electro-mechanical, and oftware based products. Experience with Microsoft Office Software (Word, Excel, Power Point, Access, Agile). Proficient in the use of an ERP System, Oracle is a plus. Knowledgeable of FDA Quality System Regulations, Current Good Manufacturing Practices, and ISO 13485 Quality Management Systems for Medical Devices. Competency in medical device risk management (ISO 14971) Competency in human factors engineering and usability engineering for medical devices (IEC 60606-1-6, IEC 62366, ANSI/AAMI HE75) Competency in medical device safety standards (IEC 60601) Competency in medical device software life cycle process (IEC 62304) Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to work with: Electronic / Mechanical Engineering tools such as AC/DC/Ohmeters, Oscilloscopes, Calipers, feeler gauges, etc. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/809C6511C40A4FE5