What are the responsibilities and job description for the Project Engineer – Spinal Implants (Additive) position at Orthofix?
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 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.
How you'll make a difference?
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.
What will your duties and responsibilities be?
The following are the essential functions of this position. This position may be responsible for performing additional duties and tasks as needed and assigned.
The requirements listed below are representative of the education, knowledge, skill, and/or ability required for this position.
Education/Certifications:
The education, knowledge, skills, and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.
Education/Certifications:
The physical requirements listed in this section include but are not limited to the motor/physical abilities, skills, and/or demands required of the position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to allow qualified individuals with a disability to perform the essential functions and responsibilities of the position.
DISCLAIMER
The duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee’s at-will employment status.
We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws.
This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.
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.
How you'll make a difference?
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.
What will your duties and responsibilities be?
The following are the essential functions of this position. This position may be responsible for performing additional duties and tasks as needed and assigned.
- 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
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
- 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).
The education, knowledge, skills, and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.
Education/Certifications:
- Bachelor’s Degree in Biomedical or Mechanical Engineering
- Spine and/or Orthopedic experience
- Additive Manufacturing/Metal 3D Printing experience
The physical requirements listed in this section include but are not limited to the motor/physical abilities, skills, and/or demands required of the position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to allow qualified individuals with a disability to perform the essential functions and responsibilities of the position.
- No additional physical requirements or essential functions for this position.
DISCLAIMER
The duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee’s at-will employment status.
We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws.
This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.
Salary : $109,300 - $155,700
