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Project Engineer

3 months ago

Carlsbad, United States Orthofix Full time
Why Orthofix?

We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Our combined company is over 1,600 strong, with products distributed in 68 countries worldwide and a global R&D, commercial and manufacturing footprint, and this is just the beginning

Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients. At SeaSpine and Orthofix our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean and Have Fun

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?

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.
What skills and experience will you need?

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, 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?

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 Engineering (Biomedical or Mechanical preferred)
Additional Experience, Skills, Knowledge and/or Abilities: Experience in spine/orthopedic preferred
PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS

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.

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

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.