Cardinal Health
Medical Devices
PrincipalEngineer,ContractManufacturing
“Principal Engineer, Contract Manufacturing at Cardinal Health. Skills: Contract Manufacturing Management, Medical Device Manufacturing, Process Engineering, Supplier Management, Cross-functional Team Leadership. Developing manufacturing processes for external sourced finished medical devices. Developing production floor layouts for external sourced finished medical devices”
What You'll Achieve.
Manage metrics targets; evaluate CM’s service, delivery, quality, compliance, and cost performance; ensure compliance with internal/external audit observation deadline or other regulatory commitments; monitor performance; drive continuous improvements across the region’s supply chain operation; driving successful design transfer and commercial prove-out
Industry & Context.
Designs process improvements to reduce product cost, process cycle time and improved product quality; Analyze and support action required for key performance indicators; Lead problem solving on production assurance, scheduling, and replanning; Provides solutions which may set precedent; Independently determines method for completion of new projects
Frequent travel visiting critical CMs multiple times per month on-site, regular on-site presence for requires approximately 50% travel within APAC, Ability to travel approximately 50% of the time
What They're Looking For.
Must Have
Bachelor's degree in Engineering or related field, At least 6+ years related work experience required in regulated industries, experience managing contract manufacturers, Ability to lead cross functional teams toward operational objectives with effective communication across engineering, quality, operations, and suppliers, Aptitude to contribute to strategic goal setting for department/business unit, Ability to travel approximately 50% of the time
Nice to Have
Biomedical Engineering, Mechatronics, medical devices, experience in PCBA transfers, PCBA component qualification, electronics manufacturing, Lean Six Sigma, PMP
What You'll Do.
Developing manufacturing processes for external sourced finished medical devices
Developing production floor layouts for external sourced finished medical devices
Developing associated tools for external sourced finished medical devices
Reviewing new designs for manufacturability
Designing process improvements to reduce product cost
process cycle time and improved product quality
Managing metrics targets and evaluating CMs' service
Establishing robust tracking and reporting processes
Ensuring compliance with internal/external audit observation deadlines or other regulatory commitments
Monitoring performance
Acting as CAH’s expert in managing technical
logistical and operational aspects of assigned projects and/or processes from initiation through commercialization
including change management
Coordinating process audits
supplier audits and 3rd party inspections
Providing on-site support for 3rd party inspections
Supporting preparation of periodic business and operations review meetings
Analyzing and supporting action required for key performance indicators
Escalating risks and tactical operational issues with CMs and CAH
Leading problem solving on production assurance
Leading/coordinating capability building
product changes/introduction/exit and corrective actions
Taking on program manager role for new product launch/supplier onboarding driving successful design transfer and commercial prove-out with cross-functional teams
How You'll Work.
Team & Collaboration
Ability to lead cross functional teams toward operational objectives with effective communication across engineering, quality, operations, and suppliers; working cross functionally to ensure compliance with internal/external audit observation deadline or other regulatory commitments; driving successful design transfer and commercial prove-out with cross-functional teams
Communication Scope
effective communication across engineering, quality, operations, and suppliers
Process & Methodology
Manage a wide variety of projects, Lead complex projects of large scope, Program manager role for new product launch / supplier onboarding, PMP certification preferred
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