Job Description

Our client is 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:

• Bachelor's degree in Biomedical, Mechanical, Electrical Engineering, or a related field.
• 7+ years of product development, program/project management, or engineering experience.
• Proven experience developing and launching Class II and Class III devices.
• Direct experience with FDA regulatory processes (PMA and 510(k) submissions) is required.
• Experience with implantable devices, particularly surgical mesh for pelvic floor disorders, is highly desirable.

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