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3D Systems, Inc. Product Development Engineer in Littleton, Colorado

3D Systems Healthcare is seeking a Product Development Engineer with experience in developing new medical device technologies from product concept to commercialization. The successful candidate will have expertise in digital surgical planning workflows, 3D printing technologies, and medical device design controls. This role requires excellent communication across a variety of stakeholders including strategic partners and key opinion leaders. This role will champion projects with cross-functional team members to deliver products and meet market needs and organizational objectives.

Primary Job Functions:

  • Lead projects for product enhancements and new product initiatives

  • Interface with key opinion leaders, customers, leadership, and cross functional teammates to define and develop product requirements and market analysis

  • File invention disclosures and work with IP counsel to conduct freedom to operate analysis

  • Own the design history file for new products

  • Create prototypes, concept drawings, and feasibility parts for testing

  • Construct verification and validation test plans, test protocols, and reports

  • Author the device master record documentation such as material specifications, standard operating procedures, work instructions, etc.

  • Ensure product development activities are in accordance with the 3D Systems QMS in addition to medical device regulations

  • Support 510(k) submissions

  • Assist with marketing and promotional activities for the Healthcare team

  • Represent 3D Systems Healthcare at conferences, customer meetings, and clinical investigation activities

Education:

Bachelor's degree in Mechanical, Biomedical, or related engineering discipline. Master's Degree preferred.

Experience:

  • 1-3 years in a medical device environment with experience in new product or process development

  • Demonstrated ability in 3D printing and digital workflows for creating patient matched medical devices

  • Understanding and experience with medical device design controls and regulatory requirements

  • Strong problem solving, decision making, root cause analysis, and interpersonal skills

  • Project management experience is highly preferred

Title: Product Development Engineer

Location: CO-Littleton

Requisition ID: 200000BX

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