Product Development Engineer 1
Job Description
Are you interested in CAD design and the medical device full product development lifecycle? In the role of New Product Design Engineer on our trauma team, you will be 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.
You will be part of a multi-functional project team working with marketing, manufacturing, quality, regulatory and other team members as appropriate to facilitate the requirements of the design project. Therefore, this role will require excellent interpersonal skills in order to optimally collaborate, both in-person and virtually, with colleagues and surgeon customers from across the globe.
What you will be doing
- You will assist with user needs collection activities using various methods including medical literature reviews, stakeholder surveys and interviews, key opinion leader (KOLs) panel discussions, and surgical observations.
- You will be responsible for definition of design inputs, prototyping, feasibility testing protocols and the concept selection process.
- You will create and maintain device/product specifications (typically includes 3D models and prints).
- You will complete 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, this includes engineering study development, evaluation, and execution, if applicable.
- You will create and maintain documentation to align with requirements of SN design control specifications and relevant regulatory bodies.
- You will be responsible for project intellectual property (IP) including creating invention disclosures, supporting patent application/prosecution, and providing technical feedback to legal regarding other IP matters.
- You will provide 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.
Requirements
Education: Bachelor's degree in Engineering (Mechanical or Biomedical preferred)
Competencies:
- Experience with 3D CAD software (UG NX, SolidWorks preferred)
- FEA and GD&T experience (preferred)
Physical Demands: Lifting & shipping prototypes & setting up labs for prototype evaluations.
Travel Requirements: 10%-20%
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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.
Date Posted
04/16/2023
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