Development Engineer

Founded in 2006, Ortho Pediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. As such it has developed the most comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. Ortho Pediatrics currently markets 53 products that serve three of the largest categories within the pediatric orthopedic market. This product offering spans trauma and deformity, scoliosis, and sports medicine/other procedures.

Ortho Pediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and over 70 countries outside the United States. For more information, please visit

The Development Engineer supports the Project Core Team over the course of a project, performing engineering tasks to bring products from conception to market release. Participates in product development and lifecycle maintenance including beginning to end activities on new and sustaining product development. Day to day activities range from collaborating with Project Core Team on design details and working with project customers (surgeons, marketing staff, and technical sales force).

Position is a supportive, subordinate role.

• Completing tasks assigned in a timely manner
• Supports Design History File and Risk Management File creation and maintenance
• Work directly with surgeons and surgical staff in an Operating Room environment to generate and validate user needs.
• Work with surgeons, sales and the Project Core Team to develop concept designs into usable products
• Solve surgical problems by applying engineering solutions through mechanical hardware
• Generate verification/validation protocols, carry out product evaluations per the protocol, and generate reports summarizing the testing
• Work with other Project Core Team members to provide information necessary for project tasks
• Communicate updates to Project Core Team and Management Team members regularly
• Understand/document project goals, work towards timeline goals
• Create 3-D CAD models and engineering drawings
• Develop an understanding of existing and new products
• Work within design controls (input, output, verification, validation)
• Creating and completing Functional Relationship Analysis (FRA) and the associated Protocols and Reports
• Work with suppliers to ensure products are cost effectively designed for manufacturability
• Perform product lifecycle management activities, including, but not limited to: investigating customer complaints, CAPAs, and executing design/documentation changes/updates.

There are no supervisory responsibilities.

• Must comprehend and understand how product is machined, cast, forged, or formed
• Work experience in regulated industry/medical devices is strongly desired
• Familiarity with CAD system-Unigraphics/NX preferred
• Familiarity with geometric tolerancing and dimensioning (GD&T)
• Must possess strong mechanical design skills
• Must be able to work on various projects as priorities change or directives are adjusted
• Ability to work within a team setting
• Ability to travel as needed

BS in mechanical or biomechanical engineering from an ABET accredited engineering school required. Candidates with medical device industry experience are strongly preferred, especially those with expertise in spinal fusion implants and related instrumentation. Knowledge of the clinical, regulatory, and technical requirements associated with spine fusion products is highly desirable.

Ability to read and comprehend instructions, correspondence, and memos. Ability to prepare routine reports and correspondence. Ability to communicate effectively with customers, vendors and other employees of the organization. Requires excellent grammar and spelling.

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

Requires a valid driver’s license.

Requires the ability to operate a variety of standard office equipment, such as a computer and keyboard, calculator, photocopier,…