Job Summary

With guidance from more senior colleagues or management, this position is responsible for the design, development, verification, and validation of new products from concept phase through design transfer, production, and launch phases using the processes and tools identified in the S&N Quality System related to Design Controls. 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.

Summary of Essential Job Functions

• (10%) Assists with user needs collection activities using various methods including but not limited to medical literature reviews, stakeholder surveys and interviews, key opinion leader (KOLs) panel discussions, and surgical observations.
• (20%) Responsible for definition of design inputs, prototyping, feasibility testing protocols and the concept selection process.
• (25%) Responsible to create and maintain device/product specifications (typically includes 3D models and prints).
• (15%) Responsible for 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.
• (10%) Create and maintain documentation to comply with requirements of S+N design control specifications and relevant regulatory bodies.
• (5 %) Responsible for project intellectual property (IP) including creating invention disclosures, supporting patent application/prosecution, and providing technical feedback to legal regarding other IP matters.
• (10%) Provides technical support to cross-functional team members including but not limited to technically reviewing marketing collaterals, providing product information for regulatory submissions, and making technical product presentations to surgeon customers and sales teams.
• (5%) Other duties as assigned.

Education: Bachelor's Degree in Engineering, minimum; Mechanical, Biomechanical or Biomedical preferred

Experience: 1 year of related design experience preferred

Competencies:

• Experience with 3D CAD software
• Knowledge of Design Controls, including CFR 820, ISO 13485, ISO 14971, preferred.
• Knowledge of basic industry-specific manufacturing and quality inspection methods, preferred.
• FEA experience, preferred
• GD&T, preferred
• Systems Engineering, preferred
• Human Factors Engineering, preferred
• Statistical Analysis (i.e., DOE, ANOVA, analysis on non-normal data), preferred.

Travel:
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.