Senior R&D Project Engineer

Our clientis seeking a Senior R&D Project Engineer to oversee projects from concept to post-market surveillance. The role requires deep expertise in developing and launching implantable Class II and III devices, navigating stringent regulatory pathways (FDA 21 CFR 820, ISO 13485, PMA / 510(k)).

Duties and Responsibilities :

• Lead the entire product development lifecycle for Class II and III implantable devices.
• Manage project plans (timelines, budgets, resources) and ensure on-time product launches aligned with strategic goals.
• Ensure strict adherence to design control and regulatory requirements.
• Translate user needs into technical specifications in collaboration with clinical, marketing, and regulatory teams.
• Oversee design, development, and testing of implantable mesh products, including material selection and prototyping.
• Manage verification / validation and draft reports to support regulatory submissions (PMA and 510(k)).
• Conduct and document risk management activities (e.g., FMEA).
• Provide technical guidance and serve as the primary liaison with external vendors.

Required Knowledge, Skills, and Abilities :