R&D Engineer I – Product Stability Services

Entry-level engineering role focused on 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.

Responsibilities

• 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.
• 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.
• 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.
• 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.

Requirements

• 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
• 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.

Skills

• 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.
• Preferred: Familiarity with medical device regulations and quality systems.
• Preferred: Experience with statistical software such as Minitab.
• Preferred: 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.

Benefits

• Medical, dental, vision, life, and disability insurance plans.
• Employee Stock Purchase Program (ESPP).
• 401K program with company match after 12 months of tenure.
• Health Savings Account (HSA) on the HDHP plan.
• SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions.
• Corporate discount savings program and other discounts.
• On-demand training program.
• Access to certification prep and a library of technical and leadership courses/books/seminars after 6+ months of tenure.
• Certification discounts and perks for associations including CompTIA and IIBA.
• Dedicated customer service team for consultants.
• Access to a certified Career Coach.