Manufacturing Engineer II

Manufacturing Engineer II

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 Collaboration Customer Centricity Developing Talent Innovation & Creativity Process Excellence Result Orientation Stakeholder Management Strategic Agility