R&D Engineer – Product Stability Services

Product Stability Engineer IPosition 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
• Experience0-2 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.
• Technical Skills 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.
• Core Competencies 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…