
Senior Technical Leader
1 day ago
Job Overview:
This is a leadership role that involves strategic management and technical ownership of complex work streams within drug delivery system development. The ideal candidate will have experience in medical device development, specifically in drug-device combination products.
Key Responsibilities:
- Strategic Management: Provide vision and direction for assigned projects, ensuring alignment with corporate objectives and regulatory strategy.
- Technical Ownership: Lead the design, validation, and lifecycle management of drug-device combination products.
- Cross-Functional Leadership: Collaborate with cross-functional teams to ensure seamless integration and successful program delivery.
- Team Development: Mentor and coach engineering managers and design engineers to build high-performing teams.
Required Skills & Qualifications:
- Technical Expertise: Advanced knowledge of GD&T, SolidWorks, injection molding, intricate mechanism design, and V&V processes.
- Regulatory Compliance: Deep understanding of FDA, EU MDR, ISO 13485, and related medical device regulatory frameworks.
- Risk Management: Ability to lead risk assessments and CAPA management initiatives.
- Communication: Strong executive communication skills to influence senior executives and regulatory bodies.
- Leadership Experience: Minimum 5-7 years of experience in people management/leadership roles with demonstrated P&L and program delivery accountability.
About Us:
We are seeking an experienced professional to join our team as a Senior Manager/Deputy General Manager. This is a unique opportunity to lead complex work streams and contribute to the development of innovative drug delivery systems.
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