Manufacturing Engineer II

Header Job Description • 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