Director of Manufacturing Engineering & Operations Excellence jobs in United States
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ZOLL Cardiac Management Solutions · 7 hours ago

Director of Manufacturing Engineering & Operations Excellence

ZOLL Itamar is an innovative medical device technology company focused on developing and manufacturing Home Sleep Apnea Tests. The Director of Manufacturing Engineering & Operations Excellence will oversee manufacturing engineering activities, ensuring product manufacturability and leading process improvement projects.

Medical Device
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H1B Sponsor Likelynote

Responsibilities

Provide strategic leadership and direction for all manufacturing engineering activities across the organization, ensuring product manufacturability, scalability, and throughout the product life cycle
Oversee and govern the New Product Introduction (NPI) processes, ensuring seamless transition from R&D to full-scale production and long-term product stabilization
Lead production engineering change (ECO) strategy, ensuring full cross-functional alignment and execution, including production readiness, documentation, and team training
Oversee the design, standardization, and capacity-based planning of production test tools and jigs, both in-house and at subcontractor sites
Responsible for the design and construction of production fixtures and tools to enhance manufacturing precision and efficiency
Drive continuous improvement in the Operations and lead projects to the finish line, while implementing different project management and LEAN manufacturing techniques
Identify and implement innovative manufacturing technologies
Establish and oversee validation strategies for new production processes, materials, and tools to ensure efficiency, repeatability, and compliance
Lead cross-functional efforts in failure analysis, root cause investigations, and yield improvements, ensuring robust corrective
Develop strategic partnerships with suppliers and subcontractors, guiding technical support, sourcing decisions, and second-source qualifications
Ensure governance and standardization of production documentation, including work instructions, technical specifications
Support compliance with global regulatory and environmental standards (e.g., RoHS, REACH, conflict minerals) through supplier coordination and documentation management
Build, mentor, and develop a high-performing engineering team, cultivating a culture of innovation, quality, and continuous improvement
Define departmental KPIs, performance metrics, and reporting frameworks to align engineering goals with business objectives
Collaborate with senior leadership to support strategic planning, resource allocation, budgeting, and cross-departmental alignment
Ensure compliance with company policies, quality systems, and industry standards
Perform other duties as assigned by executive management
Comply with all policies and standards
Any other job responsibilities as assigned by management and subject to modification

Qualification

Manufacturing EngineeringNew Product IntroductionLean Six SigmaMedical Device ProductionProduction Engineering ChangeProduction Fixtures DesignYield Improvement ProgramsProject ManagementAnalytical SkillsHebrewEnglishTeam ManagementInterpersonal SkillsCommunication SkillsAttention to Detail

Required

Bachelor's degree in Elec/Mech engineering or similar relevant field with MS or MBA preferred required
Over 10 years of experience in production engineering roles with multi-disciplinary products, including engineering leadership and management responsibilities
Experience with medical device production environment and medical device quality and regulatory requirements
Minimum of 7 years of experience in operations project management, with a focus on engineering change management and OpEx. Proven track record of successfully managing complex operations projects
Proven expertise in the design and manufacturing of production jigs, fixtures, and tooling
Strong knowledge in planning and designing manufacturing facilities, including software and hardware integration and comprehensive production line setup to ensure seamless manufacturing readiness
Experience with high-volume production processes and relevant low-cost manufacturing technologies
Experience with NPI and production ECOs processes and implementation
Hands-on PLM systems
Hands-on expertise in developing and implementing programs for yield improvements and cost reductions
Experience with safety standards and components regulations directives
Advanced certification in Lean Six Sigma and experience with lean concepts and tools implementation
Exceptional attention to detail, ability to multitask and work under pressure with excellent analytical and problem-solving skills
Professional work ethic, team player, with strong Interpersonal and communication skills
Highly organized, motivated, and independent person
Strong leadership and team management abilities

Preferred

Lean Six Sigma Black Belt certified – an advantage
Hebrew - Expert
English - Expert

Company

ZOLL Cardiac Management Solutions

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ZOLL Cardiac Management Solutions (CMS), a division of ZOLL Medical Corporation, offers a unique portfolio of novel technologies designed to deliver better insights and better outcomes in cardiac patient care.

H1B Sponsorship

ZOLL Cardiac Management Solutions has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2022 (1)
2021 (1)
2020 (2)

Funding

Current Stage
Late Stage
Company data provided by crunchbase