Manufacturing Engineer II

Description

• Develop highly capable manufacturing processes for existing products in manufacturing. Ensure robust transition from product development thru full rate production ensuring process stabilization.
• Develop, and qualify new tooling and equipment
• Update FMEA’s and QCP’s for NPI.
• Verification/Validation of processes, machines, and equipment to meet requirements of Company procedures. IQ/OQ/PQ protocols.
• Create and sustain routers and standards
• Troubleshoot product/process related issues, perform root cause analysis to develop and implement corrective and preventative action plans.
• Interface with all internal organizations with supporting new product development, introductions, technologies, and supporting systems

Qualifications

• Bachelor’s Degree in Engineering or related science discipline [required]
• Minimum 5 years of experience in a manufacturing environment
• Class III, IIb Implantable Medical Device experience
• Previous experience working in a clean room environment
• Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization
• Strong organization and follow-up skills, as well as attention to detail
• Ability to take independent decisions
• Own project level goals involving multiple engineers
• Break down ambiguous tasks into clear milestones to ensure progress can be measured
• Knowledge of Validation/Verification process, Gage R&R, and a clear understanding of FDA’s QSR and GMP
• Strong analytical, problem solving, and project management skills
• Fluent in English