Statistician - Medical Device #8996 - #304617

About ECI
ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About the Role
The Medical Device Statistician provides statistical expertise to support the design, development, validation, clinical evaluation, and post-market surveillance of medical devices. This role partners with cross-functional teams including R&D, Clinical Affairs, Quality, Regulatory Affairs, and Manufacturing to ensure statistical methodologies are appropriately applied throughout the product lifecycle and comply with applicable regulatory requirements.

What You'll Do

• Design and analyze experiments, studies, and clinical investigations to support product development and regulatory submissions.
• Develop Statistical Analysis Plans (SAPs) and provide statistical input for clinical study protocols.
• Perform statistical analyses using appropriate methodologies and software tools.
• Support Design Verification and Validation (V&V) activities, including sample size determination and data interpretation.
• Conduct statistical evaluations for process validation, risk management, and manufacturing quality improvement initiatives.
• Lead and support Measurement System Analysis (MSA), including Gauge R&R studies.
• Analyze reliability, stability, and performance data for medical devices.
• Provide statistical support for complaint trending, post-market surveillance, and CAPA investigations.
• Collaborate with Regulatory Affairs to prepare statistical content for regulatory submissions to agencies such as the U.S. Food and Drug Administration and international regulatory bodies.
• Ensure compliance with applicable standards and regulations, including design controls and statistical requirements.
• Communicate statistical findings and recommendations to technical and non-technical stakeholders.
• Review and approve statistical methodologies used by project teams and external partners.

What We Look For

• Experience supporting Class II and/or Class III medical devices.
• Experience with implantable, neuromodulation, cardiovascular, orthopedic, or diagnostic devices.
• Experience preparing statistical content for regulatory submissions.
• Familiarity with complaint trending, CAPA investigations, and post-market surveillance analytics.
• ASQ certification such as Certified Quality Engineer (CQE) or Certified Reliability Engineer (CRE) preferred.
• Strong analytical and problem-solving abilities.
• Excellent technical writing and documentation skills.
• Ability to communicate complex statistical concepts to non-statistical audiences.
• Strong cross-functional collaboration skills.
• Ability to manage multiple projects and deadlines in a fast-paced environment.
• Detail-oriented with a focus on data integrity and regulatory compliance.

ECI is an equal opportunity employer.
All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.