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
Bachelor's degree in Mechanical, Biomedical, or related engineering discipline. Master's Degree preferred.
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
Requisition ID: 200000BX