R&D Engineer – Product Stability Services

Product Stability Engineer I

Position Summary

The R&D Engineer I – Product Stability Services is an entry-level engineering role responsible for supporting product stability and expiration dating programs for sterile and non-sterile medical devices. This position contributes to the remediation, review, and approval of stability studies used to establish, maintain, or extend shelf-life claims and expiration dating support.

The engineer will collaborate with cross-functional teams including R&D subject matter experts, Design Quality, Regulatory Affairs, Packaging Engineering, Biocompatibility, and Sterilization to ensure product performance, safety, and compliance throughout the product lifecycle.

This is an excellent opportunity for a recent engineering graduate interested in medical device development, materials science, laboratory testing, and data-driven decision making.

Stability Program Support

• Support the design, execution, monitoring, and documentation of real-time and accelerated aging studies for medical devices.
• Assist with the development and review of shelf-life protocols and stability reports supporting regulatory submissions and product registrations.
• Compile, organize, and maintain stability data across multiple products and studies.
• Track study progress and ensure completion of testing activities.

Product Testing & Analysis

• Perform functional, mechanical, material, and visual evaluations of aged products.
• Analyze testing results and identify trends, anomalies, and performance concerns.
• Assist in stability-related failure investigations and root cause analysis activities.
• Support product category teams by providing recommendations based on study outcomes.
• Utilize statistical methods and data analysis tools to evaluate product performance over time.

Documentation & Compliance

• Generate and maintain protocols, reports, engineering documentation, and technical records in compliance with quality system requirements.
• Ensure study documentation meets applicable regulatory requirements and internal procedures.
• Support design control, risk management, and change control activities related to shelf-life claims.
• Participate in internal audits, external audits, and regulatory inspections as required.

Cross-Functional Collaboration

• Partner with R&D teams to establish shelf-life requirements during new product development activities.
• Collaborate with Packaging Engineering, Sterilization, Regulatory Affairs, Design Quality, and Biocompatibility teams.
• Coordinate activities with testing laboratories, suppliers, and external partners.
• Communicate technical findings and project updates to stakeholders across the organization.

Education

Bachelor's degree in Engineering or a related technical discipline.

Preferred disciplines include:

• Mechanical Engineering
• Biomedical Engineering
• Biomechanical Engineering
• Materials Science & Engineering
• Chemical Engineering
• Manufacturing Engineering

Experience

• 0-2 years of engineering experience.
• Internship, co-op, undergraduate research, or laboratory experience preferred.
• Experience in medical device, pharmaceutical, consumer healthcare, laboratory, or other regulated environments is a plus.

Required

• Understanding of engineering fundamentals, materials behavior, and product testing methodologies.
• Basic knowledge of statistics and data analysis.
• Experience using Microsoft Excel for data analysis and reporting.
• Ability to interpret technical drawings, specifications, and test methods.
• Familiarity with laboratory equipment and test procedures.
• Strong technical writing and documentation skills.

Preferred

• Knowledge of shelf-life studies, accelerated aging, or product reliability testing.
• Familiarity with medical device regulations and quality systems.
• Experience with statistical software such as Minitab.
• Exposure to sterilization processes, packaging validation, polymer science, or materials characterization.

• Strong analytical and problem-solving skills
• Attention to detail and data accuracy
• Effective written and verbal communication
• Ability to manage multiple projects and deadlines
• Strong organizational skills
• Team-oriented mindset with cross-functional collaboration abilities
• Curiosity and commitment to continuous learning