Contract Post-Market Analytics Engineer: Complaint Trends

Medical Engineering Consultants (MEC)

Minnesota

On-site

USD 90,000 - 120,000

Full time

9 days ago

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Job summary

Medical Engineering Consultants (MEC) seeks a Complaints Quality Engineer to develop and improve post-market surveillance and complaint trending, providing data-driven insights to support product quality, patient safety, and regulatory compliance. The role partners with Quality, Regulatory, Clinical, Engineering, and Risk Management to drive decision-making across the product lifecycle.

The candidate will serve as a technical resource for analytics, build dashboards and tools, and apply SPC

Qualifications

2–4 years of experience in data analytics, statistical analysis, quality engineering, post-market surveillance, or related field.
Bachelor's degree in Statistics, Mathematics, Computer Science, Engineering, Data Science, or Analytics.
Authorized to work in the U.S.

Responsibilities

Performs complaint monitoring, statistical trending, and signal evaluation activities to identify emerging product quality and patient safety concerns.
Conducts signal assessments and presents findings, recommendations, and escalations to management review boards and cross-functional stakeholders.
Develops, maintains, and improves complaint monitors aligned with risk management documentation, product hazards, and surveillance requirements.
Executes ad hoc data analyses to support Quality, Regulatory, Clinical, Engineering, and business partner requests.
Creates, maintains, and validates Power BI dashboards, visualizations, reports, and analytical tools.
Applies statistical methodologies and Statistical Process Control (SPC) techniques to evaluate product performance and identify meaningful trends.
Collaborates with Risk Management teams to ensure surveillance activities remain aligned with product risks and evolving post-market requirements.
Supports continuous improvement initiatives through automation, data visualization, and process optimization efforts.
Investigates data anomalies and develops recommendations to improve data quality, monitoring effectiveness, and signal detection capabilities.
Communicates analytical findings to both technical and non-technical audiences through clear visualizations, presentations, and written summaries.
Supports audit readiness and compliance with applicable quality system and regulatory requirements.
Contributes to the development of innovative analytical approaches, including machine learning techniques, predictive analytics, and advanced statistical methodologies where appropriate.