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Senior Design Engineer - Spine Implants

Senior Design Engineer - Spine Implants

GS Medical USASanta Ana, CA, United States
3 days ago
Job type
  • Full-time
Job description

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, we’re 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. You’ll 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

  • Bachelor’s degree in mechanical engineering (preferred) or related discipline.
  • 7-10+ years of experience in medical device design & development (Class II / III orthopedic or spine implants).
  • Direct experience developing standalone lumbar and / or expandable interbody cage systems.
  • Experience in a testing lab or tooling company is ideal (machining knowledge).
  • Hands-on experience with CNC and MTS systems alongside technicians preferred.
  • Proficiency in CAD (CREO preferred), FEA tools (ANSYS, Abaqus), GD&T, and tolerance analysis.
  • Strong understanding of design controls (ISO 13485), risk management (ISO 14971), and ASTM spine implant standards.
  • Solid background in DFM / DFA, machining, additive manufacturing, and polymer processing.
  • Excellent communication skills for surgeon interaction and cross-functional collaboration.
  • Licensed Professional Engineer (PE) highly preferred.

    • Other Preferred Qualifications

  • Instrumentation design, sterilization, and packaging validation experience.
  • Familiarity with 510(k) submissions, complaint handling, and CAPA processes.
  • Hands-on experience in cadaver labs, surgeon training, and usability evaluations.

    • Why Join Us?

    At GS Medical, you’ll 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.

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    Senior Design Engineer • Santa Ana, CA, United States