Manager, R&D Test Lab

Carlsmed • Carlsbad, CA

3d • $150,000 - $170,000

About The Position

Carlsmed’s mission is to improve outcomes and decrease the cost of healthcare for spine surgery and beyond. Its aprevo® personalized surgery platform is designed to improve the standard of care for spine surgery one patient at a time.

The Manager, R&D Test Lab leads the mechanical testing laboratory supporting the development and verification of spinal implants, instruments, and associated technologies. The role owns lab capability, equipment, capacity, test-method quality, scheduling, and technical execution, while partnering with R&D Engineering, Quality, Regulatory, and Operations. The position calls for autonomy, self-motivation, teamwork, and commitment to improving patient lives.

The manager may lead and develop test engineers, technicians, and/or lab specialists, and may coordinate with external laboratories and equipment manufacturers. Flexible scheduling may be required to meet testing demands.

Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Biomechanical Engineering, or a related field.
• 7–10 years of relevant engineering/testing experience; a master’s degree may supplement years of experience depending on focus.
• Experience collaborating with junior and senior engineers and providing technical guidance and support.
• Experience operating electromechanical or servo-hydraulic test systems, such as Instron or MTS, and working with load cells, fatigue testing, fixture design, and statistics/data analysis.
• Extensive familiarity with standards and test approaches for interbody devices, spinal constructs, fixation systems, screws, rods, plates, and instruments.
• Excellent verbal and written communication, including creating presentations and delivering them to senior management.
• Ability to write and review technical memos, protocols, and reports.
• Comprehensive understanding of product risk.
• Thorough, detail-oriented approach and ability to execute complex technical work without errors or rework.
• Willingness to take on multiple responsibilities to support Carlsmed’s mission.
• Autonomous, self-motivated, and driven to build a service department supporting cross-functional teams.

Nice To Haves

• Experience with spine or orthopedics is highly desired.
• Experience with motion-preservation, corpectomy, and other unique spinal constructs is preferred.
• A master’s degree may supplement years of experience depending on focus.

Responsibilities

• Establish and lead day-to-day operation of the mechanical testing lab and test frames, including capacity planning, prioritization, scheduling, maintenance, calibration coordination, and equipment uptime.
• Provide technical leadership for static, fatigue, torsion, compression, bending, pullout, subsidence, construct, and instrument testing in accordance with associated ASTM standards and the product portfolio.
• Oversee development, qualification, and execution of mechanical test methods, fixtures, protocols, and reports; support formal design verification and validation in accordance with the company’s QMS and applicable regulatory requirements.
• Coordinate cadaveric and animal studies with external research laboratories; develop study protocols with engineers and scientists and manage external testing partnerships, study execution, and technical reporting.
• Maintain awareness of applicable ASTM/ISO standards and FDA expectations relevant to spinal implants and instrumentation.
• Provide best practices and reference guidance to ensure testing is technically sound, repeatable, traceable, and appropriately documented.
• Partner with engineers to translate design questions and product requirements into meaningful mechanical experiments, operating as a research laboratory.
• Lead or partner with engineers to investigate complaints or field issues, production issues, anomalous results, equipment issues, test failures, and method variability.
• Improve fixtures, automation, data acquisition and analysis, test throughput, laboratory workflows, and documentation.
• Partner strategically to establish equipment and capability roadmaps based on the R&D and business pipeline.
• Own or contribute to and maintain lab CAPEX planning and equipment selection.
• Establish lab KPIs for utilization, turnaround time, uptime, on-time completion, OPEX savings, and capacity, and communicate them to leadership.
• May manage and develop test engineers, technicians, and/or lab specialists.
• May coordinate with outside testing laboratories and equipment manufacturers to complement in-house testing.
• May work a flexible schedule to align with testing demands.

Benefits

• 100% employer-paid medical, dental, and vision insurance premiums.
• 401(k) plan with employer matching.
• Unlimited paid time off (PTO).
• Eligible employees may participate in incentive compensation programs.
• Comprehensive benefits package supporting employees’ and families’ health and well-being.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager