Product Development Engineer 2

Role Overview:

With a moderate level of mentorship 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. This role falls within the Hip Product Development group where you will be responsible for hip replacement implants and instruments required to deliver those implants. The team is looking for someone to work on complex problems who can demonstrate ownership and prioritize tasks. You will collaborate with a diverse team to solve problems and execute deliverables.

Responsibilities:

• 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.
• Responsible for definition of design inputs, prototyping, feasibility testing protocols and the concept selection process.
• Responsible to create and maintain device/product specifications (typically includes 3D models and prints).
• 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. Also, includes engineering study development, evaluation, and execution, if applicable
• Create and maintain documentation to comply with requirements of SN design control specifications and relevant regulatory bodies.
• 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.
• Other duties as assigned.

Location: Memphis, TN

Education: Minimum BS in Mechanical Engineering or Biomedical Engineering with a Biomechanics Focus

Experience:

2 years of relevant experience plus BS, or 1 year of relevant experience plus Masters

Competencies:

Experience with 3D CAD software (UG NX Preferred)

Knowledge of Design Controls - including CFR 820, ISO 13485, ISO 14971.

Experience with Technical Documentation Creation including Design History Files

Knowledge of basic industry-specific manufacturing and quality inspection methods, preferred.

FEA experience, preferred

GD&T, preferred

Ability to communicate technical information to a diverse team, technical and non-technical

Travel Requirements: < 10%

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.