About this role
<div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Header</H2> </div><div></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Job Description</H2> </div><div><p>• Contribute to design transfer and continuous improvement activities by cross-functional team engagement and stakeholder management to support New Product Introduction and Sustaining Activities<br>• Collaborate with Quality to establish manufacturing process controls & quality controls on existing and new products<br>• Creates and maintains manufacturing documents including engineering drawings, BOMs & Travelers, manufacturing process instructions, and engineering change orders<br>• Coordinating engineering and production builds, including drafting manufacturing process instructions <br>• Communicate manufacturing capabilities, production schedules, or other information to facilitate production processes.<br>• Authors and perform process development activities including but not limited to Process Development, Preventive Maintenance & Calibration Requirements, IQ / OQ / PQ. <br>• Demonstrates application of Design or Experiments, SPC, Process Capability, Gage R&R and MSA for the Manufacturing Process Controls. <br>• Authors and utilize xFMEAs to identify and address potential manufacturing defects, and minimize risk to patient safety.<br>• Ability to solve complex technical problems with equipment and/or manufacturing processes using 5-why, Fishbone, Is-Is Not frameworks. <br>• Able to understand and operate semi-automatic, and automatic assembly equipment to assemble drug device combination products.<br>• Participate in vendor discussions, evaluate and recommend equipment product specifications and arrange equipment, material purchase, with the help of internal subject matter experts.<br>• Update and maintain engineering documents and files in accordance with company policy.<br>• Responsible for identifying and addressing line issues including but not limited to manufacturing process and component non-conformances, Deviations, Equipment inefficiencies. <br>• Employ Design for Manufacturing/Assembly (DFx) during product development and manufacturing process development.<br>• Design, develop and procure tooling, fixtures, and equipment in Solidworks. <br>• Ensure adherence to the applicable Standard Operating Procedures of the Quality System. </p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Qualification and Experience</H2> </div><div><p>• Minimum: BS or MS in Mechanical Engineering or equivalent and 3 Years of experience <br>• Highly Desirable: Experience in medical device industry and pharmaceutical development experience. <br>• Some experience in product design, injection molding of plastic components, testing and verification tools, equipment building and qualifications desirable. <br>• Ability to deploy Lean Manufacturing and Six-sigma principles for continuous improvement. <br>• Experience with applicable regulatory, QA, cGMP and industry best practices (ISO, ASTM and ICH standards). <br>• Prior experience with dry powder inhalers (DPI), metered dose inhalers (MDI), nasal sprays and nebulizers is preferred. <br>• Leadership and coaching skills. <br>• Demonstrated ability to communicate effectively and professionally with diverse stakeholders, including management, cross-functional teams, customers, and suppliers, across both technical and non-technical domains and multicultural environments.</p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Competencies</H2> </div><div><div>Collaboration</div><div>Customer Centricity</div><div>Developing Talent</div><div>Innovation & Creativity</div><div>Process Excellence</div><div>Result Orientation</div><div>Stakeholder Management</div><div>Strategic Agility</div></div></div></div>