Sr. Manufacturing Engineer

PURPOSE OF JOB:

• Lead SLC site-specific technical engineering projects that create, design, develop, sustain, and improve production capabilities for coating, manufacturing, and assembly operations.
• Support the product transfer plans for products planned for SLC per company/site objectives.
• Collaborate with cross-functional teams on process enhancement for continuous improvement of SLC process capabilities for safety, quality, capacity, and readiness for new product transfers.

RESPONSIBILITIES:

• Design and develop manufacturing processes for new and existing products, product changes and enhancements, and related tooling and fixtures modifications.
• Perform/manage validations on equipment (IQ/OQ/PQ) and processes as well as creating test protocols in collaboration with Quality Systems and preparing reports.
• Prepare document change orders (DCR) and coordinate the deployment of changes including training operation team members and improvement of manufacturing process instruction, forms, and logs.
• Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality, and safety performance for both current and new products.
• Support prototype and pilot production at SLC of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.
• Coordinate with site leadership, facilities, outside service providers and other subject-matter-experts to ensure reliability and performance of process equipment to deliver product to desired specifications.
• Work with product development as assigned to ensure that products under development are optimally manufacturable and to resolve manufacturing issues for future product transfers to SLC.
• Maintain GMP systems, including pre-production quality assurance as well as post-production GMP compliance in coordination with Document Control, R&D, and Quality Assurance functions.
• Complete accurate and timely manufacturing documentation including manufacturing procedures, materials records, validations, test reports, etc.
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.

PREFERRED EDUCATION:

• Bachelor’s Degree in Engineering, Materials, or Science required. Advanced degrees (MS/MBA) desirable.

PREFERRED EXPERIENCE:

• Minimum of 5 years of experience preferably in the regulated Medical Device or Aerospace industry.
• Knowledge of industry standard processes for assembly, specialty coating, and packaging of catheter systems.
• Proven project management experience contributing as either team leader, team member, or contributor.

ADDITIONAL SKILLS:

• Excellent communication, cross-functional team, interpersonal, and time management skills required.
• Training/certifications in Lean/Six-Sigma, Project Management, Statistics desirable.
• Ability to work independently or in a team setting as needed.