Design Transfer 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?

Summary Statement on overall purpose and function of the position.

The Design Transfer Engineer is responsible for leading key aspects of product design transfer to manufacturing, ensuring robust production processes, and collaborating closely with cross-functional teams to facilitate the commercialization of medical device products. This mid-level role expands on foundational skills, supporting complex design validation and driving process improvements to ensure efficient and compliant product launches.

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.

• Lead the development and optimization of processes for design transfer, ensuring efficiency and adherence to quality standards.

• Collaborate with design and development teams to evaluate and enhance manufacturability, applying Design for Manufacturing (DFM) principles.

• Act as a liaison between design and development teams and manufacturing to ensure product designs meet manufacturability requirements.

• Coordinate and conduct verification and validation activities.

• Lead process validation efforts, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

• Lead risk management activities, including Failure Modes and Effects Analysis (FMEA), to ensure product and process risks are adequately identified and mitigated.

• Author and maintain process documentation, including flowcharts, Standard Operating Procedures (SOPs), work instructions, and control plans to support regulatory audits and inspections.

• Identify, troubleshoot, and resolve technical challenges during the design transfer phase; support root cause analysis and implement corrective actions.

• Prepare and review technical documentation for regulatory submissions, ensuring compliance with industry standards and regulations.

• Facilitate design reviews and ensure timely completion of risk assessments and technical evaluations.

• Work closely with internal and external stakeholders to ensure adherence to project timelines and milestones.

• Provide technical guidance and mentorship to junior engineers, supporting their professional development.

• Monitor, report, and communicate project progress to stakeholders, including management and cross-functional teams.

• Contribute to the company’s intellectual property portfolio through innovation, patents, and technical advancements.

• Collaborate effectively with cross-functional teams, including Engineering, Manufacturing, Regulatory, Clinical Affairs, Quality, and Sales, to achieve product and business goals.

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.

• Bachelor’s degree in Mechanical, Industrial, or Biomedical Engineering, or a related field.

• Minimum of five (5) years of experience in engineering design and/or manufacturing, preferably in the medical device industry.

• Proficiency in CAD software (SolidWorks preferred) and experience creating technical drawings and applying DFM practices.

• Demonstrated experience in design transfer processes and working knowledge of medical device design controls.

• Strong analytical and problem-solving skills with the ability to drive process improvements.

• Solid understanding of engineering principles related to design transfer, process validation, and product commercialization.

• Excellent communication, organizational, and project management skills.

• Ability to lead technical discussions and communicate effectively across various teams and levels.

• Proficiency in Microsoft Project, Word, Excel, and PowerPoint.

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:

• Familiarity with ERP systems and advanced CAD software capabilities.

• Experience with risk management tools such as FMEA.

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.

• Regularly required to sit for extended periods of time; frequently required to stand, walk, and use business equipment daily (e.g., PC, copier, fax, telephone, etc.).

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.