Staff Manufacturing Engineer Job at Route 92 Medical Inc in West Jordan

PURPOSE OF JOB:

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

RESPONSIBILITIES:

• Identify and execute manufacturing or quality improvements with required documentation, tooling, and fixturing. Including managing external contractors as required.
• Initiate manufacturing process innovation by identifying and selecting new process technologies.
• Perform/manage validations on equipment (IQ/OQ/PQ) and processes as well as creating test protocols in collaboration with Quality Systems and preparing reports.
• Lead and mentor others on the design, execution, testing, analysis and interpretation of results from DOEs.
• 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.
• Lead efforts to define manufacturable product design specifications and visual standards. Work with product development to ensure products under development are optimally manufacturable.
• 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.
• 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 10 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 a team leader.

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.