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 design of a complete and complex framework, system or product.
In this job, you will:
- 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
Qualfications:
- 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.
- Excellent computer skills, including Microsoft Project, Visio, and Office.
- Familiarity with medical device design control regulations (21 CFR 820.30)
- Competency in FDA Quality System Regulations, Current Good Manufacturing Practices, and ISO 13485 Quality Management Systems for Medical Devices.
- May guide or mentor less experienced engineers (team lead opportunity).
- Travel up to 10% annually.
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.
