NPI Process Development Engineer

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    "requisitionDescription": "<div><div><div><p style='margin:0in;font-size:16px;font-family:\"Times New Roman\",serif;' data-pasted=\"true\"><strong><span style='font-family: \"times new roman\", serif; font-size: 16px;'>Job Summary</span></strong></p><p style='margin:0in;font-size:16px;font-family:\"Times New Roman\",serif;margin-right:4.3pt;line-height:115%;'><span style='font-family: \"times new roman\", serif; font-size: 16px;'>PDEs turn great designs into great products. Customers love our PDEs because they find ways to lower their manufacturing costs and make better quality products. They are experts in the science of efficient manufacturing and the art of using their &ldquo;soft skills&rdquo; &ndash; working closely with customers to negotiate and refine the tiniest details. In short, they know how to figure out the smartest way to manufacture a medical device and how to influence and guide colleagues, management, and customers.</span></p><p style='margin:0in;font-size:16px;font-family:\"Times New Roman\",serif;margin-right:4.3pt;line-height:115%;'><span style='font-family: \"times new roman\", serif; font-size: 16px;'>As a PDE you might find yourself working on ground-breaking devices from head to toe including those for cardiac surgery, neuro implants, and sports medicine.</span></p><p style='margin:0in;font-size:16px;font-family:\"Times New Roman\",serif;'><span style='font-family: \"times new roman\", serif; font-size: 16px;'><strong>&nbsp;</strong></span></p><p style='margin:0in;font-size:16px;font-family:\"Times New Roman\",serif;margin-right:4.3pt;line-height:115%;'><span style='font-family: \"times new roman\", serif; font-size: 16px;'><strong>Role and Responsibilities</strong></span></p><div style='margin:0in;font-size:16px;font-family:\"Times New Roman\",serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;margin-left: 0in;\"><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>Work in a high visibility job in a global company, collaborating with people at all levels and functions within Tegra Medical and with our customers.</li><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>Help define the project scope and support project quoting, including process, material, and NRE estimation.</li><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>Develop, drive, and support the project schedule to maintain adherence to objectives and commitments.</li><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>Work collaboratively with Quality and Operations to develop, gain support, and meet project milestones.</li><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>Support hands-on development activities related to fabrication and assembly of customer products. This includes the creation of work Instructions, training requirements, and inspection methods.</li><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>Assist in the development and completion of required validation protocols, reports, and other quality activities and documentation.</li><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>Work through Tegra Medical&rsquo;s program management system and drive projects to scaled production volumes.</li><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>Become a trusted member of the development team, working closely with the customer engineering team as you collaborate on refining their design for manufacturing.</li><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>Roll up your sleeves and put on your safety glasses as you put your ideas into action on the production floor.</li><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>There may be additional duties and responsibilities in this dynamic environment.</li></ul></div><p style='margin:0in;font-size:16px;font-family:\"Times New Roman\",serif;'><br></p><p style='margin:0in;font-size:16px;font-family:\"Times New Roman\",serif;'><span style='font-family: \"times new roman\", serif; font-size: 16px;'><strong>Level of Skill, Education and Experience</strong></span></p><div style='margin:0in;font-size:16px;font-family:\"Times New Roman\",serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;margin-left: 0in;\"><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>Four or more years of engineering experience</li><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>Bachelor&rsquo;s degree in mechanical or industrial engineering, or equivalent experience</li><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>Great interpersonal and negotiation skills, particularly when working with customers</li><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>The ability to be relied on as a key team member</li><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>An eye for details and a passion for perfection Experience with medical devices and/or ISO 13485 quality standards</li><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>Process validations (IQ/OQ/PQ requirements)</li><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>Microsoft Project (Gantt charts)</li><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>SolidWorks training</li></ul><p><br></p></div><p style='margin:0in;font-size:16px;font-family:\"Times New Roman\",serif;'><span style='font-family: \"times new roman\", serif; font-size: 16px;'><strong>Physical Requirements:</strong></span></p><ul style=\"margin-bottom:0in;margin-top:0in;\" type=\"disc\"><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>Frequent performing repetitive work</li><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>Frequent safety clothing required (safety glasses)</li><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>Constant PPE gowning&nbsp;</li><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>Occasional lifting (max. 40 lbs.)</li><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>Occasional carrying (max. 40 lbs.)</li><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>Subject to physical hazards from moving equipment and machine parts</li><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>Frequent standing</li><li style='margin: 0in; font-size: 16px; font-family: \"times new roman\", serif;'>Occasional sitting, walking, pushing, pulling, reaching</li></ul><p style='margin:0in;font-size:16px;font-family:\"Times New Roman\",serif;margin-right:4.3pt;'><strong><span style='font-family: \"times new roman\", serif; font-size: 16px;'>&nbsp;</span></strong></p></div></div></div>\n<br/>M-F Standard Office Hours",
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