Manager, R&D Test Lab

Job Description

Job Description

About Carlsmed

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

Position Description

As Manager, R&D Test Lab , you will support the Product Development team’s goal of improving patient outcomes by developing new implants, instruments, and complementary surgical planning and quality production systems that integrate with our universal platform. You will be responsible for leading the R&D mechanical testing laboratory supporting development and verification of spinal implants, instruments and associated technologies. You will own the lab capability, equipment, capacity, test method quality, scheduling, and technical execution while partnering closely with R&D engineering, Quality, Regulatory, and Operations. You will have autonomy and be expected to identify solutions to problems on your own. To be successful in this role, you must be a team-player, self-motivated , and invested in improving patient lives.

Responsibilities

• Establish and lead day-to-day operation of 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 per the associated ASTM standards and as applicable to the product portfolio.
• Oversee development, qualification, and execution of mechanical test methods, fixtures, protocols, and reports, and support formal design verification and validation activities in accordance with the company’s QMS and applicable regulatory requirements.
• Support coordinating cadaveric and animal studies with external research laboratories. Develop study protocols in collaboration 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 acting as a true research laboratory.
• Lead or partner with engineers to investigate complaints or field issues, production issues, anomalous results, equipment issues, test failures, and method variability.
• Drive improvements in fixtures, automation, data acquisition and aanalysis, test throughput, laboratory workflows, and documentation.
• Strategically partner 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 surrounding utilization, turnaround time, uptime, on-time completion, OPEX savings, and capacity and clearly communicate to leadership.
• May manage and develop test engineers, technicians, and/or lab specialists.
• May coordinate with outside lab testing and equipment manufacturers to complement in-house testing execution.
• May require flexible scheduling to align with testing demands.

Qualifications

• Education: Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Biomechanical Engineering , or related field.
• Experience: 7-10 years of relevant engineering/testing experience. A MS may supplement
  years of experience depending on focus.
• Experience collaborating with junior and senior engineers and providing technical guidance and support.
• Experience with spine or orthopedics is highly desired.
• Experience operating electromechanical test systems (or servo-hydraulic systems) such Instron or MTS, load cells, fatigue testing, fixture design, and statistics/data analysis.
• Extensive familiarity with standards and test approaches associated with interbody devices, spinal constructs, fixation systems, screws, rods, plates, and instruments. Experience with motion-preservation, corpectomy, and other unique spinal constructs is also preferred.

Skills

• Excellent verbal and written communication; comfortable creating presentations and delivering them to senior management.
• Strong ability to write and review technical memos, protocols, and reports.
• Operates with comprehensive understanding of product risk.
• Thorough and detail-oriented – able to execute complex technical work without errors or need for rework.
• Willingness to wear multiple hats when needed to support Carlsmed’s mission.
• Autonomous, self-motivated, and driven to build a service department supporting cross-functional teams.

Equal Opportunity Employer

Carlsmed is an equal opportunity employer.  All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.  Carlsmed is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know.

Compensation

The anticipated annual base salary range for this position is $150,000 - $170,000. Individual compensation is determined based on factors such as experience, skills, education, certifications, and geographic location.

In addition to base salary, eligible employees may participate in incentive compensation programs and receive a comprehensive benefits package. Our benefits reflect our commitment to the health and well-being of our employees and their families and include 100% employer-paid medical, dental, and vision insurance premiums, a 401(k) plan with employer matching, and unlimited paid time off (PTO). Your recruiter can provide additional details about our total rewards package during the hiring process.