Senior Design Engineer - Spine Implants

Direct message the job poster from GS Medical USA 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. Senior Design Engineer

(role title is represented in the text as part of the narrative) 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. Seniority level

Mid-Senior level Employment type

Full-time Job function

Engineering and Information Technology Industries

Medical Device

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