Senior Manager – New Product Development

🕒 vor 26 Tagen

🌴 South Carolina – Remote

🌴 South Carolina – Remote

⏰ Vollzeit

🟠 Senior

👔 Manager

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Zeus

WebsiteLinkedInAlle Stellen

1001 - 5000 Mitarbeiter

Gegründet 1966

⚕️ Krankenversicherung

🧬 Biotechnologie

Healthcare Insurance • Biotechnology • Medical

Zeus ist ein weltweit führendes Unternehmen im Bereich der Polymerextrusionslösungen und spezialisiert auf die Entwicklung und Herstellung innovativer Schläuche und Komponenten für verschiedene medizinische und industrielle Anwendungen. Das Produktportfolio umfasst bioresorbierbare Polymere, Schrumpfschläuche und komplexe Katheter-Baugruppen, die bei minimal-invasiven Verfahren eingesetzt werden. Mit jahrzehntelanger Erfahrung und einem klaren Bekenntnis zur Qualität konzentriert sich Zeus darauf, Lösungen zu liefern, die die Leistung und Effizienz in verschiedenen Märkten steigern.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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.