Senior Engineer New Product Development
Posted on: December 9, 2018
Job Description Summary
We are currently recruiting for a Senior Engineer New Product Development for our corporate headquarters in Alpharetta, GA.
Support feasibility, development, and commercialization of new or changing medical devices. Work with Marketing and customer groups to create product specifications through site visits and physician focus groups. Responsible for test development, protocols and reports related to verification and validation testing. Assist in Quality System compliance and regulatory filings with the FDA and other regulatory agencies.
Essential Duties and Responsibilities:
- Assist in compiling customer requirements and product specifications
- Assist in creating a Hazard and Safety/FMEA analysis
- Apply a working knowledge of materials used in medical device applications
- Conduct and document technical reviews
- Compile, organize and interpret technical data
- Manages the day-to-day operational and tactical aspects of multiple or large-scale projects
- Create contingency plans to mitigate technical risks
- Participate in studies as needed
- Design for manufacturability and develop assembly and tooling strategies for components
- Develop and conduct design verification and validation activities
- Write reports and support Regulatory filing activities
- Transfer of new products from R&D to Manufacturing
- Perform troubleshooting and defect analysis
- Create and document intellectual property according to established company procedures
- Work with cross-functional teams to support new product launchesYour qualifications
- Bachelor of Science in Mechanical or Biomedical Engineering plus 7+ years of experience developing and launching Class II medical devices; OR Master of Science plus 5+ years of experience developing and launching Class II medical devices.
- Strong analytical skills and problem-solving skills
- Ability to communicate well through written and verbal means
- Ability to interface effectively with health care professionals and medical device customers
- Solid ability to work with Microsoft Office (Word, Excel, PowerPoint, etc.)
- Working knowledge of statistical methodsAvanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law.
If you are a current employee of Avanos or Halyard Health, please apply here .
Associated topics: biochemistry, biological engineer, biomaterials, fermentation, hereditary, medical, neuroscience, parenteral, pathogenesis, pharmaceutical
Keywords: Avanos, Alpharetta , Senior Engineer New Product Development, Engineering , Alpharetta, Georgia
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