Design Engineer

Design Engineer

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.

Essential Duties and Responsibilities:

• 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.
• 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:

None

Qualifications:

• 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 2-year technical degree; BS strongly preferred. Five (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.

Reasoning Ability:

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. Ability to extrapolate design intent and functionality from the Project Lead when direct input is not provided or available.

Certificates, Licenses, Registrations:

Requires a valid driver's license.

Other Skills and Abilities:

Requires the ability to operate a variety of standard office equipment, such as a computer, calculator, fax, photocopier, scanner, telephone, cell phone, etc. Requires proficiency with Microsoft Word, Excel, Outlook and PowerPoint.

Physical Demands:

While performing the duties of this job, the employee is regularly required to sit and use hands to finger, handle or feel. The employee is occasionally required to climb stairs, talk and hear. The employee is occasionally required to stand; walk; reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and ability to adjust focus.

Work Environment:

The noise level in the work environment is that found in a "normal office environment"; noise levels during visits to other locations in the building may be moderate and occasionally loud. The employee occasionally performs work related to travel. At times this individual may be exposed to Surgical Operating Room environments.