Stability Engineer II
Stability Engineer, Product Sterility & Stability:
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 manufactured by Acelity. 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:
General w Innovation w Manufacturing w Materials w Quality w R&D
- 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 KCI 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
- Strong analytical problem solving/decision making skills are required
- Strong ability to perform root cause analysis and other key problem-solving skill sets
- Strong attention to details
- Strong critical thinking skills
- Works well with people in cross-functional, internal and external team environments and across all management levels
- This position is accountable for conformance, support and enforcement of all Company policies and procedures
Requirements – Engineering/Stability
- 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.
Requirements - Business
- Data analysis experience required.
- Proven track record of success working in a global team environment as a contributing member
- Ability to maintain confidentiality and discretion in business relationships and exercise sound business judgment
- Strong knowledge/application of MS Office applications including Excel, Project, Word, PowerPoint & Access
- Applies project management tools, critical process measures and metrics
- Travel (US & OUS) (5%)
- Experience with test method development
- Knowledgeable of statistical software, preferably MiniTab
- Bachelor’s Degree Engineering or Materials/Polymer Science with stability experience required.
- Work Experience Table:
- 2-4 Years with BS
- 0-2 Years with MS
Note: Refer to Success Profile for Additional Information
Position reports into Product Sterility and Stability managementThe information listed above is not a comprehensive list of all duties/responsibilities performed. This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice. Any physical and mental requirements described in this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EOE AA M/F/Vet/Disability: Acelity L.P. Inc. and its subsidiaries are an equal opportunity and affirmative action employer and give consideration for employment to qualified applicants without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, disability, veteran status, or genetic information or any other legally protected characteristic. If you'd like more information about your EEO rights as an applicant under the law, please click here: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf VEVRAA Federal Contractor