Manufacturing Engineer II

About the Role

Contribute to design transfer and continuous improvement activities through cross-functional team engagement and stakeholder management to support New Product Introduction and Sustaining Activities.

Responsibilities

• Collaborate with Quality to establish manufacturing process controls and quality controls on existing and new products.
• Create and maintain manufacturing documents including engineering drawings, BOMs & Travelers, manufacturing process instructions, and engineering change orders.
• Coordinate engineering and production builds, including drafting manufacturing process instructions.
• Communicate manufacturing capabilities, production schedules, or other information to facilitate production processes.
• Author and perform process development activities including Process Development, Preventive Maintenance & Calibration Requirements, IQ / OQ / PQ.
• Demonstrate application of Design of Experiments, SPC, Process Capability, Gage R&R, and MSA for Manufacturing Process Controls.
• Author and utilize xFMEAs to identify and address potential manufacturing defects and minimize risk to patient safety.
• Solve complex technical problems with equipment and/or manufacturing processes using 5-why, Fishbone, and Is-Is Not frameworks.
• 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 internal subject matter experts.
• Update and maintain engineering documents and files in accordance with company policy.
• Identify and address line issues including manufacturing process and component non-conformances, deviations, and 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 applicable Standard Operating Procedures of the Quality System.

Requirements

• Minimum: BS or MS in Mechanical Engineering or equivalent with 3 years of experience.
• Experience in the medical device industry and pharmaceutical development is highly desirable.
• Experience in product design, injection molding of plastic components, testing and verification tools, equipment building, and qualifications is 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.

Skills

• 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.