Senior R&D Project Engineer
BioTalentWestlake Village, CA, United States14 hours ago
Job type
- Full-time
Job descriptionBachelor'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.
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 :
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Senior Project Engineer • Westlake Village, CA, United States