Medical Device Product Development Senior / Engineer (Must Have Med Device Exp + Developement E[...]

Job Description:

• Lead, coordinate, and execute product development activities for blood management products, such as blood bags, in alignment with defined goals and targets.
• Define project scope, approach, strategy, market potential, pricing targets, and critical success factors.
• Manage project budgeting, scheduling, timelines, and cross-functional coordination with internal departments, customers, and suppliers.
• Conduct biocompatibility evaluations in compliance with ISO 10993, including biological testing, chemical characterization, risk assessments, and preparation of related documents (BEP, BER, BRA).
• Support regulatory submissions with biocompatibility sections (Technical Files, Design Dossiers, CERs) and maintain product compliance, technical files, and design history files.
• Plan and exec...