Associate Product Development Engineer

Job Summary

The Product Development Engineer will be responsible for supporting the research, design, and development of implants and instrumentation using primarily metal and polymer 3D printing. The position will include work along the entire product development lifecycle through launch to market including initial design and development, testing, regulatory submissions, quality system documentation, and field support.

• Supporting the design and engineering efforts for company products, which may include, but is not limited to:
• • Developing clinical use understanding of restor3d & market research through literature and interactions with internal team & surgeon design teams
  • Researching current surgical techniques and design considerations
  • Modeling implant, instrument (drivers, depth gauges, drill guides, etc.), and fixture 3D CAD models/drawings using modeling software (Solid Works)
  • Printing metal and polymer prototypes
  • Identifying feasibility and verification testing requirements and conducting testing
  • Documenting the design process in accordance with company quality procedures including development plans, design inputs & outputs, drawings, labeling, risk documentation, verification & validation plans/reports, and regulatory submission items
• Collaborating with operations, manufacturing engineers, and suppliers to support new product development and sustaining efforts
• Developing and managing project timelines for line extensions and sustaining engineering efforts

• Working with the commercial team to support launch strategy and forecasting
• Performs other related duties as assigned

• Excellent verbal and written communication skills
• Excellent organizational skills, with the ability to prioritize work.

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or equivalent Engineering
• Experience with 3D modeling software (Solidworks, ProE, 3-matic, Fusion
  360, Rhino, etc.)
• Ability to read and understand scholarly journal articles
• Independent worker willing to learn and develop necessary design, manufacturing, and software skills though guided trainings and self-guided research
• Self-starter willing to take ownership of assigned projects and action items

• Previous experience within medical device industry strongly preferred
• Knowledge of human anatomy (through coursework or training)
• Understanding of working under a quality management system for medical devices
• Demonstrated ability of working with design control activities and verification & validation activities in medical device development (ISO 13485 and FDA 21 CFR 820)
• Familiarity with orthopedic implant field
• Experience with basic hand tools, 3D printers, materials testing frames, cleaning and inspection equipment
• CSWA certification
• Ability to work flexible hours, if necessary

• Prolonged periods sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.