Project Engineer, Electronics

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?
Summary statement on overall purpose and function of the position.

Support the development of embedded orthopedic medical devices—including internal and external fixation systems—by contributing to the design, testing, and documentation of electronics and firmware as part of a multidisciplinary engineering team. The role emphasizes hands-on electrical engineering work in support of bringing regulated medical products from concept to market realization.

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. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• Assist in the development and testing of electronics and basic firmware for medical device applications, particularly for internal and external fixation systems.

• Support senior engineers in resolving technical challenges during product development.

• Help prepare product and component specifications under the guidance of experienced team members.

• Assist in the creation and execution of verification and validation test protocols, including safety, reliability, and compliance testing.

• Support process improvements and contribute ideas for increasing development efficiency.

• Collaborate with cross-functional team members (e.g., mechanical, software, QA) on project tasks.

• Contribute to Risk Management activities, including drafting FMEAs and participating in hazard analysis.

• Research and report on emerging technologies relevant to new or existing products.

• Build and test early and mid-stage prototypes and assist in developing test fixtures and procedures for transfer to production.

• Ensure compliance with Design Control processes and regulatory requirements (e.g., FDA, ISO 13485).

• Support testing and documentation related to medical device safety standards, particularly IEC 60601.

• Participate in clinical research project support as needed.

• Collaborate face to face with clinicians to capture and communicate voice of customer requirements.

• Regular attendance required.

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.

• Strong background in electrical engineering with a focus on practical applications within a regulated field with a preference for medical device experience.

• Hands-on experience with analog and digital electronic circuit design and power transfer.

• Experience supporting electronic  devices through early concept, development, and market release.

• Familiarity with schematic capture and PCB design and layout tools.

• Working knowledge and specific experience with requirements for regulated devices, particularly IEC 60601 as it relates to V&V and safety testing.

• Comfortable using lab instruments such as oscilloscopes, spectrum analyzers, and multimeters.

• Ability to prototype and test electronic breadboards and assemblies.

• Bachelor’s degree in Electrical Engineering, Systems Engineering, or Biomedical Engineering (with a strong electronics focus); candidates with Mechanical Engineering degrees may be considered if they have relevant electronics experience.

• 5+  years of relevant industry experience; internships or co-ops acceptable.

What qualifications are preferred?
The education, knowledge, skills and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.

• Exposure to QSR, ISO 13485, ISO 14971, and MDD/MDR.

• Familiarity with medical device product development lifecycle.

SUPERVISORY RESPONSIBILITIES:

• None. May receive mentorship or technical guidance from senior engineers.

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.