Senior Manager – New Product Development

🕒 Maio 11

🌴 South Carolina – Remoto

info

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

🦅 Patrocina Visto H1B

info

🗣️🇺🇸🇬🇧 Inglês obrigatório

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Zeus

1001 - 5000 funcionários

Fundada em 1966

⚕️ Seguro de Saúde

🧬 Biotecnologia

Healthcare Insurance • Biotechnology • Medical

Zeus é um líder global em soluções de extrusão de polímeros, especializada no desenvolvimento e fabricação de tubulação inovadora e componentes para diversas aplicações médicas e industriais. Sua linha de produtos inclui polímeros bioabsorvíveis, tubos termoencolhíveis e conjuntos complexos de cateteres usados em procedimentos minimamente invasivos. Com décadas de expertise e um compromisso com a qualidade, Zeus foca em fornecer soluções que melhoram o desempenho e a eficiência em múltiplos mercados.

Descrição

• Lead end-to-end new product development (NPD) programs from ideation through design, validation, understanding customer regulatory approval needs and product launch • Establish and manage integrated program plans, timelines, budgets, and resource allocations • Drive accountability across cross-functional teams to meet key milestones and deliverables • Identify, assess, and mitigate program risks; escalate issues proactively to senior leadership • Partner closely with R&D, Marketing, Quality, Operations and Supply Chain to ensure alignment and execution • Lead core team meetings and governance forums; ensure clear decision-making and communication • Coordinate design transfer to manufacturing and support scale-up activities • Ensure adherence to design control requirements, including FDA and ISO standards (e.g., design inputs/outputs, verification, validation) • Drive New Product Introduction (NPI) and commercialization readiness activities • Align launch timelines with commercial strategy and market needs

🎯 Requisitos

• Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred) • Minimum of 8 years of experience in product development and within medical devices or regulated industries • 5+ years of program/project management experience leading complex, cross-functional initiatives • Proven track record of successful product launches • Deep understanding of medical device development processes, including design controls and regulatory pathways • Strong leadership and influencing skills in a matrixed organization • Excellent project management capabilities (planning, risk management, budgeting) • Exceptional communication and executive presence • Ability to operate in a fast-paced, high-performance environment • PMP, PgMP, or equivalent certification • Experience with FDA regulations, ISO 13485, and global regulatory requirements • Familiarity with Agile or hybrid product development methodologies • Drives execution with urgency and accountability • Balances strategic thinking with operational excellence • Builds strong partnerships and aligns diverse stakeholders • Anticipates risks and navigates complexity effectively

🏖️ Benefícios

• Zeus offers an opportunity to join a very successful, family-oriented team. • Our products are cutting-edge, our process is unique, and our quality and customer focus are second-to-none. • Competitive pay and a great benefits package. • Continuous Improvement is a way of life at Zeus. • Drive lessons learned and continuous improvement initiatives across the NPD lifecycle. • Professional development opportunities.

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