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Senior NPI and Program Manager
В офисеПолная занятостьУправление программамиMedical Devices
Lead the site implementation of a global new product introduction framework while managing complex customer programs, manufacturing transfers, industrialization, validation, and production ramp-up for a medical device manufacturer in Israel.
Обязанности
- Own the Israel site rollout of the global NPI framework, including governance, processes, tools, KPIs, reporting, and cross-functional routines.
- Coordinate NPI activities across engineering, operations, quality, supply chain, commercial, and global teams.
- Track NPI performance, identify risks and delays, and drive corrective actions through qualification, validation, launch, and ramp-up.
- Manage strategic customer programs from technical introduction through industrialization, production ramp-up, and ongoing production.
- Develop project plans, milestones, dependencies, resources, risks, and deliverables while maintaining customer and stakeholder visibility.
- Lead product and process transfers from development into stable, repeatable production.
- Provide hands-on manufacturing engineering support and resolve complex production and technical issues.
- Drive production readiness across equipment, tooling, processes, documentation, training, capacity, and quality.
- Optimize and validate manufacturing processes for quality, yield, efficiency, capacity, cost, and scalability.
- Apply structured problem-solving and root-cause methods to manufacturing and quality issues.
- Lead continuous improvement and operational excellence initiatives.
- Ensure compliance with medical device quality and regulatory requirements and support audits when needed.
- Influence cross-functional teams, establish ownership and deadlines, escalate risks, and maintain execution momentum.
Требования
- Bachelor’s degree in mechanical, manufacturing, industrial, biomedical, or another relevant engineering discipline.
- Significant manufacturing engineering experience in medical devices or another highly regulated manufacturing environment.
- Senior-level experience taking products from NPI through industrialization and scaled production.
- Experience with high-volume or significant production ramp-ups.
- Strong knowledge of manufacturing processes, process optimization, validation, and continuous improvement.
- Working knowledge of medical device quality systems and regulatory requirements, including risk management, change control, nonconformances, CAPA, and controlled documentation.
- Experience leading complex cross-functional engineering or operational projects.
- Strong project planning, risk management, prioritization, and execution skills.
- Experience working directly with customers on technically complex programs.
- Strong analytical, problem-solving, communication, and presentation skills.
- Fluent English and Hebrew, including communication with global teams and senior stakeholders.
Будет плюсом
- Experience in a global medical device manufacturing organization.
- Experience implementing formal NPI or industrialization frameworks.
- Experience with contract manufacturing or multiple medical device customers.
- Experience managing major international medical device customers.
- Knowledge of Lean Manufacturing, Six Sigma, DOE, SPC, PFMEA, and process capability methods.
- Experience with automation, equipment qualification, and capacity planning.
- Project management certification or equivalent practical experience.