About this role
<div align="center"> <p> </p> <table style="width:7.25in;border-collapse:collapse;border-style:hidden" border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="width:7.25in" valign="top"> <p><strong>Location: </strong>Onsite</p> <p><strong>Status Type: </strong>Full Time</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 a technical discipline (e.g., Engineering or Science) and/or education/experience equivalent</li> <li>A minimum of 8 years of experience in process/equipment design and development to support new product development and manufacturing</li> <li>Experience leading cross functional teams, projects, and/or direct reports</li> <li>Experience with medical device manufacturing process technologies: heat staking, ultrasonic and laser welding, press assembly, robotics, leak and flow testing, functional testing</li> <li>Experience with Product DFMA (Design for Manufacturing and Assembly)</li> </ul> <p> </p> <p><strong><u>Preferred:</u></strong></p> <ul> <li>Experience in a high-volume manufacturing environment preferred, i.e., production 1M+annual, cycle time < 1 second</li> <li>Experience with custom<strong> </strong>equipment procurement and qualification such as via the GAMP process</li> </ul> <p> </p> <p><strong><u>Skills & Competencies:</u></strong></p> <ul> <li>Leadership – ability to create a vision and motivate employees to strive to create that vision</li> <li>Attention to detail</li> <li>Strong influencing and negotiating skills</li> <li>Excellent verbal communication and technical writing skills</li> <li>Proficient with spreadsheet and statistical analysis software packages (Excel and Minitab preferred)</li> <li>Understanding and application of 21 CFR 820 Medical Device Quality System Regulation, especially 21 CFR 820.70 for equipment qualification and 21 CFR 820.75 for process validation</li> <li>Experience with the validation life cycle (planning, protocol writing, execution, report writing)</li> <li>Understanding and application of Good Automated Manufacturing Practice (GAMP)</li> <li>Proficient with the MS Office Suite (Word, PowerPoint, Excel, etc.)</li> </ul> <p> </p> <p><strong><u>Physical Requirements:</u></strong></p> <ul> <li>Must be able to remain in a stationary position for extended periods of time (desk work).</li> <li>Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.</li> </ul> <p> </p> <p><strong>RESPONSIBILITIES:</strong></p> <ul> <li>Lead direct reports such as manufacturing engineers </li> <li>Delegate and prioritize tasks to align with corporate strategies</li> <li>Lead the design and development of manufacturing processes and equipment</li> <li>Review and approve manufacturing process documentation</li> <li>Creation of manufacturing process development documentation</li> <li>Equipment qualification (installation, operational and process qualifications (IQ/OQ/PQ)) to meet regulatory requirements </li> <li>Create test protocols to challenge equipment performance against intended specifications</li> <li>Execute protocols and write validation reports</li> <li>Process validation to meet regulatory requirements</li> <li>Write protocols, execution of the protocol, and write the validation report</li> <li>Standard operating procedures create, revise, and implement including necessary change order, training, and verification activities</li> <li>Test methods, write and execute test method validations such as Gauge R&R studies</li> <li>Project management, prepare overall project proposals including cost estimates and schedule for designated projects</li> <li>Assign priority and schedule tasks to provide timely solutions to achieve results</li> <li>Participate in cross functional teams</li> <li>Other duties as assigned</li> </ul> </td> </tr> </tbody> </table> </div> <p> </p>