Stability Engineer in San Antonio, TX at Volt

Date Posted: 5/8/2021

Job Snapshot

Job Description

Volt's client, a manufacturing company, is looking for a Stability Engineer for their medical devices manufacturing section. It is a contract position estimated at 12 months onsite at their facility in San Antonio, TX. It will start as a remote position.


Stability Engineer, Product Sterility & Stability:
Summary


Technical lead and subject matter expert providing stability engineering support in designating the shelf life/expiration date for all single use, terminally sterilized healthcare products that are being manufactured. To ensure that the device and sterile packaging designs, assemblies, processes, and materials meet the desired functional, performance and regulatory requirements throughout the defined lifetime of the product. Provide support to new product development teams and global operations. Provide technical solutions in the resolution of complex manufacturing problems related to packaging and product stability. This position supports both domestic and global manufacturing.


Duties and Responsibilities:

• To identify the representative product(s) and develop a stability strategy for the qualification of product expiry/shelf life.
• To technically summarize and provide conclusions of test data in support of the expiry/shelf life qualification.
• Supports the design, development and commercialization of new products through knowledge of material degradation via gamma and ethylene oxide terminal sterilization processes.
• To collaborate with packaging engineer(s) and new product introduction teams to designate a master challenge for packaging stability.
• Providing guidance and input on project specific stability planning as part of material obsolescence, COGS projects and supplier-enforced changes.
• SME who provides technical expertise and serves as a technical resource that can be deployed to address issues relating to the shelf life of products and packaging as needed across the globe.
• Acts as liaison between internal and external engineering and development teams and testing services.
• Strong ability to assist project managers in the creation of detailed project plans with specific actions for on time completion.
• Key contributor for creation/continual improvement of company stability procedures.
• Offers technical expertise and guidance to project team members/suppliers as required.
• Strong communications skills (written and oral). Including Technical communications with material vendors and contractors is required.
• Strong ability to navigate key quality processes such as Change Control and CAPA

Requirements – Engineering/Stability

Education: BS Degree in Polymer Engineering/Science or a related Engineering area.

• 2-4 years’ experience in the medical device industry with focus on material/product expiry dating.
• Proven track record with a variety of materials and compatibility with Gamma and Ethylene Oxide sterilization
• Strong technical writing skills
• Experience with design control requirements
• Experience with FDA, ISO, AAMI & ASTM Standards relating to packaging, test methods and materials aging.
 

The position is being offered through VOLT. VOLT is publicly traded on the NYSE MKT under the symbol "VOLT".  To learn more about Volt, please visit: http://www.volt.com.

Volt is an Equal Opportunity Employer.