Senior Design Engineer - Spine Implants (Santa Ana)

About GS Medical

GS Medical is a fast-growing, privately owned medical implant company headquartered in Orange County, CA. We specialize in designing and manufacturing innovative spinal implants and instruments, working closely with leading surgeons to bring next-generation technologies to market. As we expand, were seeking an experienced Senior Design Engineer to join our R&D team and lead high-impact design and development initiatives.

About the Role

This is a hands-on engineering and project leadership role that combines technical innovation with direct surgeon collaboration. Youll translate clinical needs into product solutions, drive projects from concept through commercialization, and coordinate cross-functional teams to ensure product excellence, manufacturability, and regulatory compliance.

Key Responsibilities

• Lead full-cycle design and development of interbody systems (experience with standalone and expandable cages desired), from concept to launch.
• Execute product development activities, including worst-case selections, tolerance stack-up, and failure mode analysis.
• Collaborate with surgeons to refine designs, support cadaver labs, and integrate clinical feedback into development.
• Perform engineering analyses (FEA, tolerance stack-ups, fatigue / strength calculations) and iterate designs.
• Develop CAD models, drawings, BOMs, and inspection plans; apply GD&T per ASME Y14.5.
• Conduct competitive benchmarking, IP reviews, and risk assessments.
• Oversee design verification / validation activities per ISO 13485 and relevant ASTM standards.
• Partner with suppliers and manufacturing teams to optimize DFM / DFA for titanium, PEEK, and additive manufacturing.
• Support regulatory submissions (510(k)) and contribute to design control documentation.
• Manage project milestones, surgeon communications, and cross-functional coordination.

Qualifications

Other Preferred Qualifications

Why Join Us?

At GS Medical, youll help shape the future of spinal technology while working side by side with surgeon innovators. This role offers the chance to lead high-impact projects, grow within a rapidly expanding company, and see your designs directly improve patient care.