Senior Design Assurance Engineer

**Description:**The Sr Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system. You will work closely with Regulatory Affairs personnel (internal or external) to monitor regulatory compliance. You will monitor quality assurance efforts to ensure that the company's products conform to quality standards. You will partner with research/development and manufacturing engineering during new product start-ups and establishes checkpoints for testing new products and processes. The design assurance engineer is responsible for following established GMP/ISO compliant quality system practices.Essential Functions:1. Ensure company's adherence to the established Quality System and GMP/ISO standards, including ongoing establishment and improvement to the quality system procedures.2. Lead design assurance activities in support of development for electromechanical systems that utilize microcontroller technology, customized/off the shelf PCBs and software applications.3. Manage new product Design History Files.4. Work with Engineering, Marketing, Manufacturing and Regulatory to establish measurable, valid product requirements.5. Aide in definition of test equipment as required to accomplish quality responsibilities.6. Develops and documents test plan protocols, test procedures, and test reports.7. Perform tests according to various protocol requirements.8. Lead completion of risk management and risk analysis including FMEA.9. Devise design verification and design validation plans for products based on performance specifications and risk analysis10. Analyze and communicate conformance to specifications and standards.11. Conducts technical and statistical investigations concerning compliance to specification and optimization of design relevant to specification.12. Support completion of in vitro testing including applicable animal studies.13. Aide in definition of supplier quality specifications, sampling plans, and vendor qualification.14. Assist in specifications and testing of sterilization methods.15. Lead system and product continuous improvement teams.16. Reviews Engineering Change Orders, as required.17. Perform other duties and responsibilities as assigned by management.Details:stages of development. It is scheduled to be a 12-18 month project with strong possibility to be extended or converted. It will be a blend of on-site and remote about 50/50, but it is a requirement that this individual has the ability to be on site between 2 and 3 days per week.\#LIJOBS**About Aerotek:**We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing?? Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.