Product Support Engineer II

Company: Smith & Nephew
Location: Austin
Posted on: January 24, 2023

Job Description:

Job Overview:This position is responsible for the design, development, verification, and validation of products post- launch phase which may include but not limited to design changes, design transfers, production changes, and product obsolescence using the processes and tools identified in the S&N Quality System related to Design Control and Engineering Change Control. - This position is a functional member of a cross-functional project team working with marketing, manufacturing, quality, regulatory and other team members as appropriate to facilitate the requirements of the design project. -Responsibilities:

• Provide technical guidance to product support engineers and technical staff, as appropriate.
• Provides R&D engineering support for Quality and compliance activities including correcting quality problems in released product, compliance with new regulations and standards, support for Regulatory submissions for expansion into new geographies, and remediation of quality records. -
• Consults with the marketing staff, sponsoring surgeons, and manufacturing staff, as required, to facilitate proper design and development of agreed product improvements.
• Responsible for the creation and accuracy of device/product specifications (typically includes 3D models and prints). -
• Identifies and mitigates any impact to design integrity of current product from process changes or supplier/network changes, including completion of design verification and validation activities by developing or collaborating with testing partners to develop biomechanical and mechanical test methodologies when consensus testing standards are not applicable. - Also, includes engineering study development, evaluation, and execution, if applicable.
• Supports returned product labs, complaint investigations, retrieved component analysis, and post market surveillance with root cause analysis.
• Provides technical support as required for existing products (e.g., sales training, product demonstrations, customer meetings, VSPs, tradeshows.)
• Supports R&D activities related to product obsolescence and end of life management for all assigned products.
• Other duties as assigned. - -Location: Austin, TexasREQUIREMENTSEducation: minimum BS in EngineeringExperience:
  • 2 years of experience + BS in Engineering
  • 1 year of experience + Masters in EngineeringLicenses/ Certifications: Professional Engineering Certification PreferredCompetencies:
    • Experience with 3D CAD software.
    • Knowledge of Design Controls - including CFR 820, ISO 13485, and ISO 14971.
    • Knowledge of basic industry-specific manufacturing and quality inspection methods, preferred.
    • GD&T, preferred
    • Statistical Analysis (i.e., DOE, ANOVA, analysis on non-normal data), preferred.
    • Usability Assessment experience, preferred.Travel Requirements: - Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

Keywords: Smith & Nephew, Austin , Product Support Engineer II, Engineering , Austin, Texas