Research Manager

Job Summary:

We are seeking a skilled and detail-oriented Research Manager to lead and oversee the testing operations in our accredited Westminster Mechanical Test Lab. Individual will manage a team responsible for the design, execution, and documentation of mechanical testing protocols for our innovative spine medical devices. This role ensures that all testing complies with regulatory requirements, industry standards, and company objectives.

Principal Duties and Responsibilities:

• Lab Management:
  1. Oversee the daily operations of the mechanical test lab, including scheduling, resource allocation, budget, and maintenance of equipment.
  2. Develop and maintain lab policies, procedures, and safety protocols.
• Testing & Analysis:
  1. Plan and execute mechanical testing of spinal implants and instrumentation, including static, dynamic, fatigue, and coordination of wear testing.
  2. Review and approve test protocols, methodologies, and reports in compliance with ISO 17025 and industry standards (e.g., ASTM F1717, F2077).
  3. Ensure accurate data collection and provide detailed analyses of test results to support design verification and validation activities.
• Leadership & Team Development:
  1. Lead and mentor a team of test engineers and technicians to achieve high performance and maintain quality standards.
  2. Foster a culture of innovation, collaboration, and continuous improvement.
  3. Collaborate closely with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams to address technical challenges, resolve issues, and optimize testing needs.
• Compliance & Documentation:
  1. Maintain detailed and organized test records for audits and regulatory submissions.
  2. Collaborate with regulatory and quality assurance teams to ensure testing aligns with global standards.
  3. Drive continuous improvement initiatives to enhance product quality, reliability, and cost-effectiveness.
• Equipment & Technology:
  1. Manage the procurement, calibration, and maintenance of test lab equipment, including Instron and MTS systems.
  2. Identify and implement new testing technologies to improve efficiency and accuracy

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

Expected Areas of Competence (i.e., knowledge, skills, and abilities)

• Strong understanding of mechanical testing principles, biomechanics, and material properties.
• Proficiency in mechanical testing software and tools, including Instron, MTS, or similar systems.
• Excellent project management, problem-solving, and leadership abilities.
• Familiarity with regulatory standards (e.g., ISO 13485, ISO 10993) and FDA guidelines.
• Excellent communication, leadership, and interpersonal skills, with the ability to collaborate effectively across functional teams and external customers.
• Experience with CAD software (e.g., SolidWorks) and finite element analysis (FEA) tools preferred.
• Prior experience in the spine industry and familiarity with relevant anatomical considerations and surgical techniques is a plus.
• Candidate must have demonstrated self-directed working capabilities. 
• Demonstrated ability to methodically investigate and resolve problems using current technology. 
• Knowledge of project management tools.
• Comfortable working in a fast paced, cross disciplinary environment
• Able to work with minimal direction towards completing project tasks
• Demonstrated good written and verbal communication skills including presentation skills. 
• Leads or participates in the creation and improvement of processes 

Education/Experience Requirements 

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field; advanced degree (MS ) preferred.
• Minimum of 7 years of experience in mechanical testing of spine medical devices or orthopedic implants.  
• Managerial experience preferred with proven track record in test lab or similar environment. 

Travel Requirements

              Minimal