Product Manager Injectables

Spearheading customized medical device and component development projects with a focus on product innovation, regulatory compliance, and commercial viability. Leveraging comprehensive expertise across the complete product development lifecyclefrom initial concept through scale-up and commercialization.

Key Responsibilities:

• Managed end-to-end customized development projects for medical devices and specialized components, with emphasis on understanding and translating client requirements into viable product solutions.
• Directed product development initiatives encompassing design validation, regulatory pathway analysis, and manufacturing scale-up strategies for medical device/components
• Collaborated with cross-functional teams to evaluate emerging medical device standards, testing protocols, and regulatory requirements (FDA, ISO series, ASTM for medical devices/components especially pre-filled syringes, hypodermic needles, biocompatibility assessments).
• Conducted comprehensive material selection and biocompatibility analysis for pre- filled syringes, hypodermic needles.
• Coordinated needle design optimization, including bevel angle analysis, tip sharpness assessment, and insertion force validation to ensure clinical performance and patient safety. Managed pre-filled syringe development including plunger design, compatibility with pharmaceutical formulations, and extractables testing per ISO and USP standards.
• Developed manufacturing process optimization strategies to transition from prototype to commercial-scale production for injectable components.
• Managed vendor evaluation and supply chain optimization for specialized medical device components (pre-filled syringes, hypodermic needles, biocompatible polymers).
• Experience in compiling and maintaining Design History Files (DHF) in line with USFDA design control and quality system requirements.
• Strong understanding of USFDA guidelines, 510(k) premarket notification requirements, and supporting technical documentation, including DMF-related inputs for components and materials.
• Exposure to patents and IP, including prior-art searches, and freedom-to-operate (FTO) assessments to de-risk new product development and commercialization