Lead Research And Development Engineer

The Lead R&D Engineer is primarily responsible for generating creative designs of Spine implants and surgical instruments which are mechanically and clinically feasible, conducting tests to analyze their performance, and completing supporting FDA regulated documentation.

Lead R&D Engineer Responsibilities:

• Creates Computer Aided Design CAD models, assemblies, and drawing using Solidworks CAD system.
• Works with Engineering team and outside supplier to ensure specifications contain proper level of detail required to provide quality product.
• Completes Design History File (DHF) documents in accordance with ISO 13485 regulations.
• Assists in the design and construction of test fixtures and prototypes to accomplish assigned project and testing goals.
• Writes test protocols and reports, including test objectives and interpretation of data.
• Support sustaining activities for existing product lines.
• Maintains organized archive of all design concepts and files.
• Performs dimension and tolerance analysis on part assemblies.
• Performs in a self-directed environment to support production schedules.
• Participates and contributes to decision-making process.
• Provides status updates to the supervising engineer and other engineers submitting work requests.
• Works with personnel in related areas to coordinate activities and to achieve desired results.
• Performs projects with minimal supervision; completed work is reviewed for technical adequacy and satisfaction of requirements.
• Participates in facilitated training and development programs designed to increase knowledge in issues related to medical device manufacturing and development, such as good manufacturing practice (GMP), Total Quality, etc., as well as their application.

Background requirements:

• Bachelor's degree (B.S.) in Engineering with 5+ years of experience in Medical Devices.
• Experience in Spine implant/ instrument development (or other orthopedics) required.
• Master’s degree (M.S.) or higher in Mechanical or Biomedical Engineering may be substituted for years of industry experience.
• Expert level Solidworks CAD modeling including: parametric modeling, design tables, linked dimensional relationships, configurations, and surfacing.
• Expert level understanding of geometric dimensioning and tolerancing (GD&T).
• At least three (3) years’ experience with Solidworks CAD system.
• Excellent understanding of mechanical theory.
• Able to work a flexible schedule to include weekends and holidays.
• May require some travel on an as-needed basis.