Senior Design Engineer
OrthoPediatricsAbout the role
Founded in 2006, OrthoPediatrics 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. OrthoPediatrics 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. OrthoPediatrics’ 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 www.orthopediatrics.com.
GENERAL SUMMARY: The Design Engineer is responsible for researching, designing and developing medical products (implants and instruments) within the assigned business unit, using CAD to generate electronic 3D Models. Those models will be verified to work as intended, and subsequently turn in to a specification print.
Using computer software and complex 3D mathematical models to design, develop and test new material, devices and equipment. This can involve: building and evaluating prototypes; troubleshooting problems; and rethinking the design until it works correctly.
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Utilizing parametric techniques, sketcher, spreadsheets, freeform, and assembly tools within the 3D software supported by OrthoPediatrics.
- Liaising with technicians and manufacturers to ensure the feasibility of a product in terms of design and economic viability.
- Discussing and solving problems with manufacturing, quality, purchasing and marketing departments.
- Creating and completing Functional Relationship Analysis (FRA) and the associated Protocols, Reports, and Layouts in the defined conditions.
- Applying current ISO 13485, GD&T, and ASME standards to engineering prints.
- Work in a strong team environment.
- Use of MasterControl as a database to store and link required documentation.
SUPERVISORY RESPONSIBILITIES: There are no supervisor responsibilities with this position.
QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. (The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).
- Ability to adjust priorities and manage time wisely in a fast-paced environment.
- Maintain documents and records pertaining to research and development.
- Communicate and work well with customers.
- Read, listen and communicate effectively in English, both verbally and written.
- Be results oriented, requiring knowledge and experience in a wide variety of disciplines.
- Ability to travel as needed.
- Work independently with minimal direction.
- § Demonstrate problem solving skills with high proficiency.
EDUCATION AND/OR EXPERIENCE: Requires a 4-year technical degree in Engineering discipline. 3-5 years related engineering/design experience. Broad machine design experience. Broad exposure to metal and plastic fabrication technologies. Proven skills with defined CAD packages. Ability to use ISO 13485 design controls and
regulations related to projects, which result in meeting global regulatory guidelines and policies. Good verbal and written (MS Word) communication skills. Medical device development experience preferred.
LANGUAGE SKILLS: 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 through written and oral communication.
MATHEMATICAL SKILLS: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent.
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