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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:

Define processes for technical platforms, system specifications, input/output, and working parameters for hardware and/or software compatibility. Conceive system interfaces and business application prototypes. Identify, analyze, and resolve system design weaknesses. Influence the shaping of future products across multiple processes or systems. Provide multi-layered technical experts for next generation initiatives. Supports the deinclude the following.sign of a complete and complex framework, system or product.

In this job, you will:

  • Works in a cross functional team, including test engineers, technicians, mechanical engineers, program management, software, manufacturing, and supply chain to achieve success
  • Broad use and application of systems, mechanical and electrical engineering principles, concepts, theories and techniques to solve problems related to product support, manufacturing, and design.
  • Authors and maintains product and project documentation required by the Quality Management System.
  • Stays up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers.
  • Delivers medical device design documentation compliant with FDA design controls and good documentation practices
  • Creates inputs to the medical device Design History Files
  • Supports investigations and resolves product related Corrective and Preventative Actions using appropriate problem solving techniques (DMAIC, FMEA, Ishikawa, Fault Tree, etc.)
  • Other duties may be assigned. Travelis required (up to 10%).

Qualifications:

  • Bachelor’s degree in system engineering or other engineering discipline and a minimum of 2 years of relevant experience, or an advanced degree in system engineering or related discipline without experience, or equivalent combination of education and work experience. May guide or mentor less experienced engineers (this position is a team lead).
  • Excellent computer skills, including Microsoft Project, Visio, and Office.
  • Experience with requirements management tools such as DOORS
  • Familiar with medical device risk management (ISO 14971)

  • Familiar with Risk and Opportunity Management

  • Competency in human factors engineering and usability engineering for medical devices (IEC60606-1-6, IEC 62366, ANSI/AAMI HE75)

  • Competency in medical device software life cycle process (IEC 62304) a plus

  • Competency in medical device safety standards (IEC 60601)ompetency with PLM and Product Data Management (PDM) systems

Benefits:

Natus offers competitive salaries, comprehensive benefit package that starts on your 1st day, 401k match, an employee stock purchase plan, 9 paid holidays, generous paid time off plan (4 weeks) and tuition reimbursement up to $5,000 annually.

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