About this role
<div align="center"> <table style="width:696.0px;border-collapse:collapse;border-style:hidden" border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="width:7.25in" valign="top"> <p><strong>Location: Onsite</strong></p> <p><strong>Status Type: Full Time</strong></p> <p> </p> <p><strong>QUALIFICATIONS</strong></p> <p><strong> </strong></p> <p><strong><u>Required:</u></strong></p> <ul> <li>Bachelor’s Degree in Engineering discipline</li> <li>A minimum of 2 years of device/combo product design and development experience, working in a highly regulated environment, quality, manufacturing, or engineering <ul style="list-style-type:circle"> <li>Master’s Degree considered as an additional 2 years of experience</li> </ul> </li> </ul> <p><strong> </strong></p> <p><strong><u>Preferred:</u></strong></p> <ul> <li>ASQ Certified Quality Engineer (CQE), ASQ Certified Reliability Engineer (CRE), Six Sigma Yellow/Green/Black Belts, and/or other similar certifications</li> <li>Quality Engineering Experience</li> </ul> <p><strong> </strong></p> <p><strong><u>Skills & Competencies:</u></strong></p> <ul> <li>Basic knowledge of Risk Management, device manufacturing, and statistical analysis techniques including use of Minitab (or comparable) software</li> <li>Possess a good balance of basic technical expertise, analytical thinking, and communication skills for resolving issues internal and external to the organization</li> <li>Comfortability in speaking with external partners regarding business need</li> <li>Competent with word processing, spreadsheet and statistical analysis software packages (preferably Word, Excel and Minitab)</li> <li>Strong time management skills</li> <li>Work to acquire and develop new skills</li> <li>Ability to apply competency in difficult situations</li> <li>Engages colleagues with the Enable Values in mind</li> <li>Ability to follow defined procedures and proactively diagnose</li> <li>Ability to collaborate and maintain cooperative work relationships with others</li> <li>Ability to adapt to change and handle unexpected situations, Requires occasional guidance</li> <li>Ability to maintain a positive attitude, show empathy for others, and always do the right thing</li> <li>Ability to have a positive impact on others in support of company goals and a healthy work environment</li> <li>Ability to stay focused on tasks, organize, compare, and interpret data and assess problems with little guidance</li> <li>Shows inquisitiveness about how situations are evolving and identifies how to adapt early to changing situations</li> </ul> <p> </p> <p><strong><u>Physical Requirements:</u></strong></p> <ul> <li>Must be able to gown and work within a clean room and/or lab environment. </li> <li>Ability to lift and lower boxes of documents or handle equipment weighing up to 25 lbs.</li> <li>Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.</li> <li>Position requires being physically present on the premises during regular company hours or as approved by management</li> </ul> <p> </p> <p><strong>RESPONSIBILITIES:</strong></p> <ul> <li>Support Senior Engineers with any platform and partner needs</li> <li>Ensure product quality targets are achieved by supporting the design and implementation of test plans</li> <li>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</li> <li>Guide the identification and traceability of requirements from Feasibility through Design Release. Ensure platform requirements are defined, verifiable, and are not redundant</li> <li>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</li> <li>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</li> <li>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</li> <li>Provide analysis and evaluations to support investigations, bounding, root-cause investigation and corrective actions per the corrective and preventative action program</li> <li>Incorporate assessments of operational performance, product quality and the effectiveness of corrective actions into the risk-management documentation for the platform</li> <li>Proactively communicate project risks and status to management and external partners as needed</li> <li>Manage other job functions and duties; and provide for other product development projects, teams and activities as required</li> <li>Provides project status to leadership</li> </ul> <p> </p> </td> </tr> </tbody> </table> </div> <p> </p>