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• Contribute to design transfer and continuous improvement activities by cross-functional team engagement and stakeholder management to support New Product Introduction and Sustaining Activities
• Collaborate with Quality to establish manufacturing process controls & quality controls on existing and new products
• Creates and maintains manufacturing documents including engineering drawings, BOMs & Travelers, manufacturing process instructions, and engineering change orders
• Coordinating engineering and production builds, including drafting manufacturing process instructions
• Communicate manufacturing capabilities, production schedules, or other information to facilitate production processes.
• Authors and perform process development activities including but not limited to Process Development, Preventive Maintenance & Calibration Requirements, IQ / OQ / PQ.
• Demonstrates application of Design or Experiments, SPC, Process Capability, Gage R&R and MSA for the Manufacturing Process Controls.
• Authors and utilize xFMEAs to identify and address potential manufacturing defects, and minimize risk to patient safety.
• Ability to solve complex technical problems with equipment and/or manufacturing processes using 5-why, Fishbone, Is-Is Not frameworks.
• Able to understand and operate semi-automatic, and automatic assembly equipment to assemble drug device combination products.
• Participate in vendor discussions, evaluate and recommend equipment product specifications and arrange equipment, material purchase, with the help of internal subject matter experts.
• Update and maintain engineering documents and files in accordance with company policy.
• Responsible for identifying and addressing line issues including but not limited to manufacturing process and component non-conformances, Deviations, Equipment inefficiencies.
• Employ Design for Manufacturing/Assembly (DFx) during product development and manufacturing process development.
• Design, develop and procure tooling, fixtures, and equipment in Solidworks.
• Ensure adherence to the applicable Standard Operating Procedures of the Quality System.

Qualification and Experience

• Minimum: BS or MS in Mechanical Engineering or equivalent and 3 Years of experience
• Highly Desirable: Experience in medical device industry and pharmaceutical development experience.
• Some experience in product design, injection molding of plastic components, testing and verification tools, equipment building and qualifications desirable.
• Ability to deploy Lean Manufacturing and Six-sigma principles for continuous improvement.
• Experience with applicable regulatory, QA, cGMP and industry best practices (ISO, ASTM and ICH standards).
• Prior experience with dry powder inhalers (DPI), metered dose inhalers (MDI), nasal sprays and nebulizers is preferred.
• Leadership and coaching skills.
• 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.

Competencies