Project Engineer, Engineering Design & Technologists

Position Title: Project Engineer

Location: Carlsbad

Position Type: Full time

Guided by our organizational values Take Ownership |
Innovate Boldly |
Win Together we collaborate closely with world‑class surgeons and other partners to improve people’s quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech.

Our global team of over 1,600 employees brings to market highly innovative, cost‑effective, and user‑friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people’s lives? Look no further.

The Orthofix Product Development team is looking to expand its network and source for additional talent, specifically in our spinal deformity space. We’re excited about new, future projects that will propel the business further, so if you are interested in learning more about the organization, please submit your resume.

Here’s what we’re hoping to attract:

• Project Engineer (please refer to the job description below)
• Focused on mechanical design of access or interbody systems
• Experience in spine preferred, ideal to have exposure to complex mechanisms (i.e. expandables or access systems)
• Bachelor of Science in Mechanical Engineering or equivalent

The Project Engineer manages development of medical device systems from concept through market introduction 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.

The following are the essential functions of this position. This position may be responsible for performing additional duties as tasks as needed and assigned.

• Lead design projects to develop and commercialize medical implant & instrument systems. Coordinate cross‑functional teams to complete project plans, product requirements, design & process specifications, verification & validation, and other DHF deliverables in accordance with Design Controls and Risk Management procedures.
• Generate 3D models and detailed engineering drawings using Creo CAD software to develop new device designs and/or sustain existing systems.
• Perform testing and analysis to ensure that designs satisfy functional and performance requirements. Draft protocols, reports, technical memos, and other documentation in accordance with Quality procedures.
• Engage with surgeons, Sales team partners, and other field associates to support product development, marketing, and training activities.
• Interface with vendors to address technical questions and supervise designs throughout the manufacturing process.
• Perform other duties as assigned.

The requirements listed below are representative of the education, knowledge, skill and/or ability required for this position.

Education/Certifications
:

• Bachelor’s Degree in Engineering

Experience, Skills, Knowledge and/or Abilities
:

• 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, Solid Works, 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
• Ability to utilize a computer, telephone, fax and copy machine as well as other general office equipment
• Strong computer…