Research And Development Engineer

Long term W2 temporary position in Memphis, TN for a large Medical Device Manufacturing company

• (20%) Provides R&D engineering support for Manufacturing Transfer, 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.
• (15%) Consults with the marketing staff, sponsoring surgeons, and manufacturing staff, as required, to facilitate proper design and development of agreed product improvements.
• (15%) Responsible to create and maintain device/product specifications (typically includes 3D models and prints).
• (15%) 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.
• (10%) Supports returned product labs, complaint investigations, retrieved component analysis, and post market surveillance with root cause analysis.
• (10%) Provides technical support as required for existing products (e.g. sales training, product demonstrations, customer meetings, VSPs, trade shows.)
• (5%) Supports R&D activities related to product obsolescence and end of life management for all assigned products.
• (5%) Other duties as assigned.

• BS in Engineering or Science +4 years experience or Masters in Engineering or Science +2 years of

• Experience with 3D CAD software [required for positions within Orthopaedic and Sports Medicine divisions].
• Knowledge of Design Controls – including CFR 820, ISO 13485, and ISO 14971, required.
• Knowledge of basic industry-specific manufacturing and quality inspection methods, preferred.
• FEA experience, preferred
• GD&T, preferred
• Statistical Analysis (ie. DOE, ANOVA, analysis on non-normal data), preferred.
• Experience with ethnographic research, preferred.
• Usability Assessment experience, preferred.