Manufacturing Engineer II

Lupin Ltd; Florida; On-site; USD 90,000 - 120,000; Full time

Job summary

Lupin Ltd in Florida seeks an experienced mechanical engineer to support New Product Introduction and Sustaining Activities in a medical device setting. You will engage cross-functional teams and manage stakeholders to drive design transfer and process improvements.

The role involves collaborating with Quality to implement manufacturing controls, maintaining engineering documents, and supporting equipment qualification and process development activities.

Qualifications

• BS or MS in Mechanical Engineering or equivalent.
• 3 years of experience minimum.
• Experience in medical device industry and pharmaceutical development is highly desirable.
• Lean Manufacturing and Six-Sigma expertise preferred.
• Knowledge of regulatory, QA, cGMP and ISO/ICH standards is beneficial.

Responsibilities

• Contribute to design transfer and continuous improvement with cross-functional teams.
• Collaborate with Quality to establish manufacturing process controls and quality controls.
• Create and maintain manufacturing documents (engineering drawings, BOMs, Travelers, process instructions, ECOs).
• Coordinate engineering and production builds and draft process instructions.
• Communicate capabilities, schedules and information to facilitate production processes.
• Perform process development activities including IQ/OQ/PQ and calibration requirements.

Skills

Cross-functional collaboration

Stakeholder management

Manufacturing process control

DFx (design for manufacturing)

Root cause analysis

Quality systems

Communication with diverse teams

Education

BS or MS in Mechanical Engineering

Tools

SolidWorks

Job description

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