Principal Engineer
Apply NowCompany: Orthofix International NV
Location: Carlsbad, CA 92009
Description:
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 Principal Engineer is responsible for partnering with franchise engineering leads to support technical efforts within and across Development franchises to bring highly technical medical device systems from concept through market introduction in accordance with FDA and ISO requirements. Furthermore, the Principal Engineer will provide field support for complex ongoing sustaining challenges on existing products. They will lead individuals / teams on project activities that include technical design and project team coordination to address a variety of highly complex technical problems that require specialized knowledge. The Principal Engineer will work with engineering management to assume technical responsibilities for all projects within or between various franchises, depending on the needs of the franchise. The Principal Engineer may manage a team of Staff or other engineers focused on technical assistance and / or business development. Those engineers will either assist Principal Engineer on large, complex projects or manage projects of their own.
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.
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:
Experience, Skills, Knowledge and/or Abilities:
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:
Additional Experience, Skills, Knowledge and/or Abilities:
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.
The anticipated salary for this position for an employee who is located in California is $170,817 to $212,054 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.
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 Principal Engineer is responsible for partnering with franchise engineering leads to support technical efforts within and across Development franchises to bring highly technical medical device systems from concept through market introduction in accordance with FDA and ISO requirements. Furthermore, the Principal Engineer will provide field support for complex ongoing sustaining challenges on existing products. They will lead individuals / teams on project activities that include technical design and project team coordination to address a variety of highly complex technical problems that require specialized knowledge. The Principal Engineer will work with engineering management to assume technical responsibilities for all projects within or between various franchises, depending on the needs of the franchise. The Principal Engineer may manage a team of Staff or other engineers focused on technical assistance and / or business development. Those engineers will either assist Principal Engineer on large, complex projects or manage projects of their own.
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 teams to develop and commercialize complex medical implant and instrument systems Establish project plans, develop product requirements, and coordinate other team activities in accordance with Design Control and Risk Management procedures
- Explore (confidential) Business Development ideas and ventures to vet integration opportunities
- Engage and lead business development activities, exploratory development, and various unbudgeted and unplanned proactive investigations
- Support franchise team Managers/Directors with their teams' technical requirements (Design consulting, DFM, manufacturing support, Design Reviews, Independent reviewers, etc.)
- Participate in, support, and supervise additional critical-to-business design projects through personnel management, dedicated project consulting within and across franchises, and technical mentorship
- Effectively interact with interdepartmental personnel and external partners to uphold project plans and achieve project objectives
- Generate complex implant and instrument CAD models and detailed engineering drawings using ProEngineer/Creo software to develop new device designs and/or maintain existing products
- Generate and analyze test data and reports to verify that designs meet functional and performance specifications
- Interface with vendors on technical issues while supervising designs throughout the manufacturing process
- Provide training, mentorship, and supervision to junior product development staff
- Proactively identify and correct recurring design issues across product development through education and training
- Assist with field sales support and training
- Develop intellectual property based on developed products
- Attend, participate in, and lead departmental meetings as scheduled
- 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:
- 12+ years' experience in medical devices
- Demonstrated ability leading teams and completing several projects on time and on budget with minimal supervision
- Expertise in FDA QSR and ISO 13485 principles, including Design Controls and Risk Management
- CAD experience required (Pro-Engineer/Creo, SolidWorks, or equiv.)
- Strong computer skills are required including proficient and accurate usage of CAD software (Pro-Engineer/Creo preferred), word processing (Word), spreadsheets (Excel), charting, flow charting, and graphs
- Ability to utilize a computer, telephone, fax, scanner, and copy machine as well as other general office equipment
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:
- Master's Degree in Engineering (Biomedical or Mechanical)
Additional Experience, Skills, Knowledge and/or Abilities:
- No additional requirements
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 $170,817 to $212,054 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.