Product Support Engineer II
Company: Smith & Nephew
Posted on: January 24, 2023
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
- 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,
- 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
- 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
- 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
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