Operations Consultant optimizing operational structures for an innovative mobility company. Engaging in projects for shared mobility and autonomous driving initiatives.
About the role
- Manager of NPI Technical Operations leading technical execution for contract manufacturing in cardiac imaging systems. Collaborate in developing manufacturing strategy and overseeing compliance with quality standards.
Responsibilities
- Support the development and execution of Conavi’s external manufacturing strategy to enable scale-up from pilot to full commercial production
- Contribute development of the long-term technical roadmap for external partners including capacity, automation, and cost-reduction priorities
- Lead all technical aspects of new product transfer from R&D to contract manufacturing ensuring robust process definitions and validations
- Establish and maintain comprehensive documentation packages (PFMEA, process flow, control plans, IQ/OQ/PQ)
- Oversee production readiness, yields, and technical support for high-mix, low-volume catheter builds and related subassemblies
- Partner with Contract Manufacturing teams to troubleshoot production issues and drive corrective actions
- Lead performance reviews with Contract Manufacturing partners covering quality, delivery, cost and technical capability metrics
- Lead initiatives to reduce cost of goods sold (COGS) through process optimization, material strategy, and supplier consolidation
- Ensure the deployment Lean and Six Sigma methodologies to improve throughput, reduce scrap, and enhance process stability at contract manufacturers
- Ensure all external operations are in compliance with FDA, ISO 13485 and MDSAP standards
- Collaborate with R&D to ensure smooth design transfer and lifecycle support
- Work closely with Quality to maintain robust CAPA, non-conformance, and change control processes at the Contract Manufacturers
- Partner with Supply Chain and Finance to align technical decisions with sourcing strategy and cost targets
- Attract, retain, and motivate technical operations staff
Requirements
- Bachelor’s or higher degree in Engineering (Mechanical, Biomedical, Manufacturing, or related field)
- Significant experience in medical device manufacturing, process development, or technical operations
- Proven success in managing outsourced manufacturing partners and executing technology transfers
- Deep understanding of catheter assembly, micro-mechanical processes, and complex electromechanical integration
- Strong working knowledge of quality system regulations (FDA 21 CFR 820, ISO 13485, MDSAP)
- Demonstrated leadership in scaling operations, improving yield, and reducing cost in a regulated environment
- Competencies include communications, accountability, and collaboration
- Ability to travel to supplier sites across North America as required
Benefits
- Join our collaborative team in the design, manufacture, and sale of an innovative intravascular imaging system to improve cardiac care
- Conavi Medical values everyone and their contributions. We value diversity and encourages applications from all qualified candidates.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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