Description
The Senior Product Development Engineer of Design Assurance is responsible for the quality and reliability of new products including appropriateness of design inputs, adequacy of verification and validation testing, and identification of key quality characteristics for the device.
Requirements
Basic Qualifications:
� Bachelors Degree in Materials, Biomedical or related engineering field.
� At least 8 years quality experience and reliability engineering with new product development
� Experience with MS Office applications including Word, Excel, PowerPoint, and OutLook
Other Qualifications:
� Knowledge of Risk Assessment and experience with ISO 14971
� Regulatory experience with Underwriter's Laboratory (UL) and International Electrotechnical Commission (IEC) standards
� Experience in print and specification review
� Demonstrated Six Sigma expertise in manufacturing and design of new products
� Demonstrated problem solving skills, ability to diagnose issues, find and test solutions.
� Ability to deal effectively with all employees and external business contacts while conveying a positive, service oriented attitude.
� Ability to communicate technical subject matter effectively to technical and non-technical audiences.
� Ability to deal with all employees and external business contacts while conveying a positive, service oriented attitude.
� Ability to maintain confidentiality and discretion in business relationships and exercise sound business judgment.
Preferred Qualifications:
� Masters Degree in Material, Biomedical or related engineering field.
� Experience in a regulated design environment with medical device development
� FDA or ISO registered work experience.
� Experience in Manufacturing Practices(GMP) certified Manufacturing Processes and UL, IEC Standards.
� Experience in developing Software Requirements and conducting Software Validation
� Experience in medical device development, FDA or ISO registered work.
� Experience in Manufacturing Processes, UL, IEC standards
