Orthofix · 2 days ago
Project Engineer
Carlsbad, CA
Full-time
Onsite
Senior Level
$99K/yr - $158K/yr
5+ years expOrthofix is a company focused on improving people's quality of life through innovative medical technologies. The Project Engineer will manage the development of medical device systems, coordinating technical design and project teams to solve complex problems while ensuring compliance with FDA and ISO requirements.
BiotechnologyHealth CareMedical
Responsibilities
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
Qualification
Required
Bachelor of Science in Mechanical Engineering or equivalent
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
Ability to utilize a computer, telephone, fax and copy machine as well as other general office equipment
Strong computer skills are required including proficient and accurate usage of CAD software (Creo preferred), word processing (Word), spreadsheets (Excel), presentations (PowerPoint), flow charting, and graphs
Preferred
Bachelor's Degree in Engineering (Biomedical or Mechanical preferred)
Experience in spine/orthopedic preferred
Benefits
Bonus
Benefits
Company
Orthofix
Orthofix is a global medical device company.
1001-5000 employees
H1B Sponsorship
Orthofix has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (1)
2023 (2)
2022 (5)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$160M2024-11-07Post Ipo Debt· $160M
1992-05-01IPO
Leadership Team
Andres Cedron
Chief Legal Officer
Clay Aiena
Chief Information Officer
Recent News
2025-12-24
MarketScreener
2025-11-04
2025-11-04
Company data provided by crunchbase