Design Verification / Test Automation Engineer

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?

Establish and implement verification and testing standards for our bone growth therapy (BGT) devices.  Perform, document and automate verification testing, including hardware, firmware and App related aspects of the BGT devices.

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.

• Develop and execute design verification and validation protocols for medical devices and Software per regulatory requirements (FDA, ISO 13485, IEC 60601, ISO 14971, etc.).

• Design and develop test plans, test cases, and test scripts for both software and hardware components of medical devices.

• Set up and operate test equipment, including mechanical, electrical, and software-based systems.

• Perform functional, performance, and reliability testing to ensure compliance with design specifications.

• Analyze test data, identify deviations, and collaborate with design teams for corrective actions.

• Prepare and maintain detailed verification reports, traceability matrices, and risk assessments.

• Ensure verification activities comply with regulatory standards such as FDA 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971, and IEC 60601.

• Support the creation of regulatory submissions (510(k), PMA etc.) by providing necessary verification documentation.

• Work closely with design, quality, and manufacturing teams to improve product designs based on test results.

• Participate in design reviews, risk management activities (FMEA), and CAPA investigations.

• Support automation of verification tests to enhance efficiency and repeatability.

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 or master’s degree in biomedical engineering, Electrical Engineering, Mechanical Engineering, or related field.

Experience, Skills, Knowledge and/or Abilities:

• 3+ years of experience in medical device verification & validation (V&V).

• Strong knowledge of medical device regulations and standards (FDA, ISO 13485, IEC 60601, ISO 14971, etc.).

• Experience in test method development, test automation, and statistical analysis.

• Proficiency in test equipment, data acquisition tools, and failure analysis techniques.

• Familiarity with risk management tools (FMEA, DFMEA, AFMEA).

• Strong documentation and technical writing skills for regulatory submissions.

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:

• N/A

Additional Experience, Skills, Knowledge and/or Abilities:

• Experience with software verification & validation (IEC 62304) for medical devices.

• Hands-on experience with LabVIEW, Python, MATLAB, or other test automation tools.

• Knowledge of Good Manufacturing Practices (GMP) and Design Control principles.

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.

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.