- Posted 13 October 2025
- LocationWestlake Village
- Job type Permanent
- Reference224139
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Sr. Project Engineer
Job description
Senior Project Engineer
Our client is seeking a key leader in medical device R&D 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)).
This person will manage project timelines, budgets, and deliverables while ensuring products meet the highest standards of safety, efficacy, and quality through collaboration with cross-functional teams.
Duties and Responsibilities:
Our client is seeking a key leader in medical device R&D 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)).
This person will manage project timelines, budgets, and deliverables while ensuring products meet the highest standards of safety, efficacy, and quality through collaboration with cross-functional teams.
Duties and Responsibilities:
- Lead the entire product development lifecycle for Class II and III implantable devices, with an emphasis on women's health.
- 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.
- 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.
- Annual Salary: $110,000 - $130,000
- Travel Required: 10-20%
- Benefits include: Medical and Dental (75% paid for employee/family), Vision, 401(k) with 4% match (after 90 days), Basic Life/AD&D, Unlimited Vacation Policy, 6 Weeks Paid Maternity Leave, and 10 paid holidays (including your birthday).