Sr Engineer Advance Operation

What you will do:

• Coordinate with partners/end users to deliver value to business through opportunity identification, execution, and solution delivery.
• Ensure quality of process and product as defined in the appropriate operation and material specifications.
• Will select components and equipment based on analysis of specifications, reliability, and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.
• May lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
• Will analyze equipment to establish operating data, conduct experimental test and result analysis. Lead and/or participate in process review meetings.
• Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product launches.
• Complete capability studies for in process inspection and generate subsequent Inspection documentation.
• Conduct MSA studies for new products and new processes.
• Provide training for manufacturing team members.
• Ensure adherence to GMP and safety procedures.
• Review and approval of validation documentation.
  
  

• Bachelor’s degree (B.S.) in Mechanical or related engineering discipline required.
• 4+ years of work experience required
  
  

• Good knowledge of manufacturing processes, materials, product, and process design
• Project Management experience
• Ability to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.
• Experience in an FDA regulated or ISO 3485 regulated industry- highly preferred.
• Good understanding of Design for Manufacturing (DFM) related statistical tools and validation/verification techniques.
• US visa