Engineer II, Quality

Qualifications Bachelor’s Degree in Engineering discipline A minimum of 2 years of device/combo product design and development experience, working in a highly regulated environment, quality, manufacturing, or engineering Master’s Degree considered as an additional 2 years of experience Preferred ASQ Certified Quality Engineer (CQE), ASQ Certified Reliability Engineer (CRE), Six Sigma Yellow/Green/Black Belts, and/or other similar certifications Quality Engineering Experience Basic knowledge of Risk Management, device manufacturing, and statistical analysis techniques including use of Minitab (or comparable) software Possess a good balance of basic technical expertise, analytical thinking, and communication skills for resolving issues internal and external to the organization Comfortability in speaking with external partners regarding business need Competent with word processing, spreadsheet and statistical analysis software packages (preferably Word, Excel and Minitab) Work to acquire and develop new skills Ability to apply competency in difficult situations Engages colleagues with the Enable Values in mind Ability to follow defined procedures and proactively diagnose Ability to collaborate and maintain cooperative work relationships with others Ability to adapt to change and handle unexpected situations, Requires occasional guidance Ability to maintain a positive attitude, show empathy for others, and always do the right thing Ability to have a positive impact on others in support of company goals and a healthy work environment Ability to stay focused on tasks, organize, compare, and interpret data and assess problems with little guidance Shows inquisitiveness about how situations are evolving and identifies how to adapt early to changing situations Physical Requirements Must be able to gown and work within a clean room and/or lab environment. Ability to lift and lower boxes of documents or handle equipment weighing up to 25 lbs. Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc. Position requires being physically present on the premises during regular company hours or as approved by management Responsibilities Support Senior Engineers with any platform and partner needs Ensure product quality targets are achieved by supporting the design and implementation of test plans Provide the design team with statistical guidance including sample size selection, test method validation strategies, and defining evidential requirements to support risk-management claims and mitigations Guide the identification and traceability of requirements from Feasibility through Design Release. Ensure platform requirements are defined, verifiable, and are not redundant Sponsor a robust execution of Risk Management activities throughout all phases of development and assurance the identified risks have been reduced as far as possible Ensure that requirements are appropriately defined and tested and that the stress-conditions appropriately challenge the design to insure regulatory and pharma-partner needs are satisfied by the assigned subsystems Guide various process and product development activities through sample-size determination, distribution identification and data analysis; and other means such as the selection, support and appraisal of inspection plans and process controls Provide analysis and evaluations to support investigations, bounding, root-cause investigation and corrective actions per the corrective and preventative action program Incorporate assessments of operational performance, product quality and the effectiveness of corrective actions into the risk-management documentation for the platform Proactively communicate project risks and status to management and external partners as needed Manage other job functions and duties; and provide for other product development projects, teams and activities as required #J-18808-Ljbffr