Project Engineer - Spinal Implants (Additive)

About the position

The Project Engineer - Spinal Implants (Additive) manages the development of medical device systems and supports integration of technology in accordance with FDA and ISO requirements. Responsibilities include both technical design and project team coordination to address a variety of complex technical problems. Work requires some supervision and draws upon significant experience and developing leadership abilities.

Responsibilities

• Leads design projects to develop and commercialize medical instruments that integrate with complex enabling technology systems
• Effectively creates and manages project plans, timelines, and budgets to mitigate risk and achieve project objectives
• Coordinates cross-functional teams to complete product requirements, design and process specifications, verification and validation, and other DHF deliverables in accordance with Design Controls and Risk Management procedures
• Generates complex 3D models and detailed engineering drawings using Creo CAD and/or SolidWorks software to develop new device designs and/or sustain existing systems
• Performs testing and analysis to ensure that designs satisfy functional and performance requirements. Drafts protocols, reports, technical memos, and other documentation in accordance with Quality procedures
• Engages with surgeons, sales team partners, and other field associates to support product development, marketing, and training activities
• Interfaces with vendors to address technical questions and supervise designs throughout the manufacturing process
• Performs other duties as assigned

Requirements

• Bachelor's Degree in Engineering
• 5+ years in related medical device engineering role
• Key contributor to multiple development projects. Ability to develop/co-develop detailed project schedules and manage execution by cross-functional teams with general guidance or assistance
• Established technical abilities for basic to complex device design, modeling, and detailed engineering drawing generation using CAD software (Creo, SolidWorks, or equiv.)
• General understanding of Design Controls and Risk Management principles per FDA and ISO requirements with significant contributions made to DHF documentation
• Basic understanding of clinical applications and how to leverage knowledge to create high-performing designs
• Ability to work effectively with inter-departmental personnel and external partners to achieve project objectives
• Strong computer skills are required including proficient and accurate usage of CAD software (Creo and/or SolidWorks preferred), word processing (Word), spreadsheets (Excel), presentations (PowerPoint), flowcharting, and graphs.

Nice-to-haves

• Bachelor's Degree in Biomedical or Mechanical Engineering
• Spine and/or Orthopedic experience
• Additive Manufacturing/Metal 3D Printing experience

Benefits

• Salary range of $109,300 to $155,700 per year, plus bonus and benefits