Principle Engineer

Job Description

Job Summary:

• Analyzes product performance and post-market surveillance data to develop, maintain, and continuously improve complaint monitoring strategies.
• Applies statistical concepts, product knowledge, risk-based decision making, and cross-functional collaboration to establish appropriate product complaint trending criteria and document supporting rationale.
• Partners with quality, clinical, regulatory, manufacturing, and engineering stakeholders to ensure monitoring approaches remain effective, compliant, and aligned with product risk profiles throughout the product lifecycle.

Duties & Responsibilities:

• Leads or supports projects focused on developing, maintaining, and improving product complaint monitoring strategies and criteria.
• Evaluates complaint data, product risk profiles, lifecycle characteristics, and usage patterns to determine appropriate monitoring methods and thresholds.
• Develops, documents, and defends the rationale for product-specific trending criteria using statistical principles and engineering judgment.
• Partners with cross-functional stakeholders including Product Development, Manufacturing, Clinical, Regulatory, Quality, and Complaint Investigation teams to ensure monitoring approaches remain appropriate and effective.
• Reviews and periodically reassesses existing monitoring strategies to ensure they remain aligned with product performance, risk, and regulatory requirements.
• Performs complaint trending analyses and investigates potential signals, anomalies, or emerging product performance concerns when identified.
• Documents technical justifications, monitoring decisions, peer reviews, and supporting evidence in accordance with quality system requirements.
• Supports implementation and continuous improvement of complaint monitoring processes, work instructions, and best practices.
• Uses Excel and other available tools to evaluate complaint and product performance data, generate supporting analyses, and maintain documentation.
• Participates in audits, inspections, and quality system activities related to complaint monitoring and post-market surveillance processes.
• Acts as a technical resource for complaint trending methodologies, monitoring criteria development, and post-market performance evaluation.
• May mentor less experienced employees and lead cross-functional initiatives related to complaint monitoring and signal detection.

Required Skills:

• Statistical reasoning and application of basic-to-intermediate statistical methods.
• Product complaint trending and signal detection.
• Technical writing and rationale documentation.
• Cross-functional collaboration and stakeholder engagement.
• Problem solving and critical thinking.
• Project management and organization.
• Advanced Microsoft Excel.

Required Education :

• Bachelor’s degree in Engineering, Quality, Statistics, Life Sciences, or a related technical field.
• 7+ years of experience in medical device quality, post-market surveillance, complaint handling, complaint trending, reliability engineering, product performance monitoring, or a related field.
• Working knowledge of statistical concepts and their practical application to quality and product performance monitoring.
• Experience developing, evaluating, or maintaining complaint trending, monitoring, or signal detection methodologies.
• Strong Microsoft Excel skills, including data manipulation, trend evaluation, and reporting.
• Demonstrated ability to apply technical judgment and risk-based thinking to solve complex problems.
• Strong written and verbal communication skills with the ability to document and explain technical rationale to diverse audiences.

Preferred Qualifications:

• Experience within the medical device industry.
• Experience with complaint handling, post-market surveillance, or product performance monitoring programs.
• Knowledge of FDA post-market surveillance expectations, EU MDR PMS activities, or related quality system requirements.
• Experience participating in cross-functional reviews involving Quality, Regulatory Affairs, Clinical, Manufacturing, or Product Development.
• Experience developing technical reports, justifications, engineering assessments, or quality documentation.
• Familiarity with statistical process control, control charts, trend detection methodologies, or quality engineering techniques.