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    "requisitionDescription": "\n    <link href=\"https://static.workforcenow.adp.com/mas/mdf-components/22.3.26/styles/froala_editor.pkgd.min.css\" rel=\"stylesheet\" type=\"text/css\" />\n    <link href=\"https://static.workforcenow.adp.com/mas/mdf-components/22.3.26/styles/froala_style.min.css\" rel=\"stylesheet\" type=\"text/css\" />\n\n    <div class=\"fr-view\">\n      <div><div><div><div><div><div><div><div><div><div><p style='margin:0in;font-size:16px;font-family:\"Calibri\",sans-serif;color:black;'><strong><span style=\"font-size: 12px; font-family: georgia, serif;\">SUMMARY:&nbsp;</span></strong><span style=\"font-size: 12px; font-family: georgia, serif;\">This position is responsible for the following areas: In-House and Contracted Manufacturing, Manufacturing Engineering, and Equipment Planning/Engineering in accordance the company&rsquo;s Quality System and customer requirements. This position will ensure that assigned projects product/s are designed to facilitate manufacturability and will be responsible for technology transfer to manufacturing and, ultimately, scalability for&nbsp;</span></p><p style='margin-top:0in;margin-right:5.6pt;margin-bottom:.0001pt;margin-left:0in;text-indent:0in;font-size:16px;font-family:\"Arial\",sans-serif;line-height:103%;'><span style=\"font-family: georgia, serif; font-size: 12px;\"><strong><span style=\"line-height: 103%;\">&nbsp;</span></strong></span></p><p style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style=\"font-family: georgia, serif; font-size: 12px;\"><strong>ESSENTIAL DUTIES AND RESPONSIBILITIES&nbsp;</strong></span><span style=\"font-size: 12px; font-family: georgia, serif;\">include the following. &nbsp; Other duties may be assigned on an individual basis:</span></p><ul style=\"list-style-type: disc;margin-left:-0.25in;\"><li style=\"font-family: georgia, serif; font-size: 12px;\">As a technical individual contributor or team leader, oversee the construction of fixtures for new products or processes or current product enhancements.</li><li style=\"font-family: georgia, serif; font-size: 12px;\"><span style=\"color: rgb(38, 38, 38);\">Manage in-house and contract manufacturing activities and relationships to ensure products are manufactured in accordance with product plans and quality/regulatory requirements</span>&nbsp;</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Ensure Supply Chain is aware of inventory, raw materials, and component requirements per the planned build schedule; manage and be accountable for material issued to production or engineering projects</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Develop manufacturing processes and Manufacturing Process Instructions (MPI&rsquo;s) and lot history records (LHR&rsquo;s) in collaboration with R&amp;D and Quality</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Perform time studies for each manufacturing process and identify process development initiatives&nbsp;</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Individually or through direct reports, ensure that all products are manufactured in compliance with the company Quality System, customer needs, budgetary requirements, schedule requirements, and the regulatory requirements</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Work with Quality personnel to define in-process inspections and testing and resolve quality and yield issues through continuous improvement projects&nbsp;</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Provide oversight and coordinate cross-functional operations project team activities from early project conceptualization through clinical testing&nbsp;</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Create, maintain, and manage manufacturing tasks of project schedule, and ensure that critical timelines and/or budgets are established and met&nbsp;</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Participate in manufacturing team meetings to ensure adequate communication between members and develop positive, proactive working relationships with other staff</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Develop manufacturing specifications for products; coordinate all process validation activities with Quality- IQ/OQ/PQ&nbsp;</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Determine tooling, equipment, and fixture needs for the timely and cost-effective manufacture of products&nbsp;</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Work with R&amp;D staff to ensure smooth transition of products into manufacturing while assuring manufacturability, achieving cost targets and conformance with regulatory and quality requirements</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Work with suppliers to ensure parts/services are properly documented and meet specifications&nbsp;</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Manage specifications for sub and final assemblies; identify tooling requirements &ndash; design/document/procure/verify tooling&nbsp;</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Establish manufacturing line and approve DCO&rsquo;s for manufacturing engineering&nbsp;</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Train/Certify the MPI Trainer for manufacturing process instructions; may train other staff as needed&nbsp;</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Work with Purchasing and Accounting to establish, monitor, and manage supply agreements. Maintain accurate cost data and work with accounting to update QAD to establish cost standards&nbsp;</li></ul><p style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style=\"font-family: georgia, serif; font-size: 12px;\"><strong><u><span style=\"text-decoration:none;\">&nbsp;</span></u></strong></span></p><p style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;margin-left:.25in;text-indent:-.25in;'><span style=\"font-family: georgia, serif; font-size: 12px;\"><strong><u>EDUCATION/EXPERIENCE: &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</u></strong></span></p><p style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;'><span style=\"font-size: 12px; font-family: georgia, serif;\">&nbsp;</span></p><ul style=\"list-style-type: disc;margin-left:-0.25in;\"><li style=\"font-family: georgia, serif; font-size: 12px;\">BS or MS in Engineering or related discipline or equivalent experience in the medical device industry.</li><li style=\"font-family: georgia, serif; font-size: 12px;\">10+ years increasingly responsible, relevant experience in the medical device industry</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Knowledge of and experience in pilot/production line set up and validation in Controlled Environment</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Ability to detail project plans effectively</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Familiar with GMP, GDP procedures and requirements</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Familiar with Design Control procedures and requirements</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Excellent communications skills (both written and verbal) required</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Ability to work independently or in team setting required</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Project management experience preferred</li><li style=\"font-family: georgia, serif; font-size: 12px;\">Must be able to travel</li></ul><p style='margin:0in;font-size:13px;font-family:\"Times New Roman\",serif;text-align:justify;'><span style=\"font-size: 12px; font-family: georgia, serif;\">&nbsp;</span></p></div></div></div></div></div></div></div></div></div></div>\n    </div>\n  \n",
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