Senior Manager – New Product Development

🕒 il y a 1 mois

🌴 South Carolina – Distant

🌴 South Carolina – Remote

⏰ Temps Plein

🟠 Senior

👔 Manager

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Zeus

Site WebLinkedInTous les Emplois

1001 - 5000 employés

Fondée en 1966

⚕️ Assurance santé

🧬 Biotechnologie

Healthcare Insurance • Biotechnology • Medical

Zeus est un leader mondial dans les solutions d'extrusion de polymères, spécialisé dans le développement et la fabrication de tubes innovants et de composants pour diverses applications médicales et industrielles. Leur gamme de produits comprend des polymères bioabsorbables, des tubes thermorétrécissables, et des assemblages complexes de cathéters utilisés dans des procédures peu invasives. Avec des décennies d'expertise et un engagement envers la qualité, Zeus s'attache à fournir des solutions qui améliorent la performance et l'efficacité sur plusieurs marchés.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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.