Why Orthofix?
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 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 :
We're excited about new, future projects that will propel the business further, so if you are interested in learning more about the organization and what we're looking to build, please submit your resume.
How you'll make a difference?
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 to a variety of complex technical problems. Work requires some supervision and draws upon significant experience and developing leadership abilities.
What will your duties and responsibilities be?
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.
What skills and experience will you need?
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, 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).
What qualifications are preferred?
Education / Certifications :
Bachelor’s Degree in Engineering (Biomedical or Mechanical preferred)
Additional Experience, Skills, Knowledge and / or Abilities :
Experience in spine / orthopedic preferred
PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS
No additional physical requirements or essential functions for this position.
The anticipated salary for this position for an employee who is located in California is $98,661 to $157,659 per year, plus bonus, and benefits.
DISCLAIMER
Project Engineer • Carlsbad