R&D Engineer I - Product Stability Services

Job#: 3047507

Job Description:
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.
Key Responsibilities
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.

Required Qualifications
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.

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 mindset with cross-functional collaboration abilities
• Curiosity and commitment to continuous learning

Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.

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Everforth Apex Benefits Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Everforth Apex team member can provide.

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