Orthopedic Surveillance Engineer

hace 2 semanas


San José, San José, Costa Rica Microport Orthopedics S.A. A tiempo completo

Job Description

At MicroPort Orthopedics S.A., we are dedicated to advancing orthopedic innovation and excellence. As a key member of our team, you will play a critical role in ensuring the highest standards of product safety and regulatory compliance.

About the Role:

  • Conduct comprehensive Post-Market Surveillance (PMS) activities, analyzing product complaints, reviewing international registries, and summarizing literature reviews to inform regulatory submissions.
  • Schedule and facilitate PMS review team meetings, writing and distributing meeting minutes, and following up on action assignments to ensure timely completion.
  • Assist the Regulatory Affairs group with new product submissions and license renewals, providing PMS review findings and supporting government agency inquiries.
  • Support Product Development Engineers in developing DFMEA and Risk Analysis plans for new products, reviewing and approving these documents.
  • Assist with conducting literature searches and MAUDE database searches for initial Clinical Evaluation Reports.

Key Responsibilities:

  • Organize and conduct PMS meetings according to established schedules.
  • Prepare complaint rates and trends reports, providing key analysis of product safety.
  • Search, review, and summarize published information on clinical data for MPO and competitive products.
  • Assist in writing initial Clinical Evaluation Reports.
  • Review Device Registries and government databases for MPO and competitive products.
  • Write and distribute summary PMS reports, updating electronic databases.
  • Routinely update CERs with new PMS data after each PMS review.
  • Provide training on Post Market Review procedures and database management to new employees.
  • Collaborate with departments to identify and analyze trends from product complaints, clinical studies, competitive products, and literature reviews.
  • Provide input on identifying failure modes and risk assessment for new products under development, reviewing FMEA reports.
  • Analyze, interpret, and disseminate results from clinical studies.
  • Create and update Clinical Evaluation Plans (CEPs), Summary of Safety and Clinical Performance (SSCP), and Periodic Safety Update Reports (PSURs).

Requirements:

  • Bachelor's Degree in a Science/Engineering/Technical field or related degree required; Master's Degree preferred.
  • Minimum 1 year of related experience, including a combination of internship and/or research experience.
  • Familiarity with basic orthopedic knowledge, such as anatomy, diseases of joints, and joint replacement science.
  • Strong leadership skills, excellent analytical and problem-solving abilities, good communication skills, and technical writing skills.
  • Ability to work well within a team environment, balance multiple projects, timelines, and outputs.


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