R&D Engineer

Roles & Responsibilities:

• Serve as R&D Lead on New product development and product engineering initiatives focused on changes to existing products and design changes.
• Guides the successful completion of major programs and may function in project leadership role.
• Independently determines and develops approach to solutions.
• Represents the organization as the prime technical contact on contracts and projects.
• Supports material/design/process changes to the product line through design control process, with well-documented research/analyses.
• Demonstrates accountability for successful and timely completion of designated tasks.
• Develops technical solutions to complex problems using sound engineering principles, utilizing experimental, computational and analytical methods.
• Designs and develops in vivo and in vitro models to evaluate product features & improvements.
• Applies innovative & logical risk based approach to product development challenges with the capacity for original thinking.
• Develops robust test methods, design test fixtures and execute measurement system analysis.
• Ensures compliance with Client quality policies, procedures, and practices through appropriate communication, training and education of sound quality assurance principles.
• Plans, executes and analyzes design of experiments (DOE).
• Writes implements and leads bench studies, tolerance stack up analysis, design verification, validation, vendor interactions, materials specifications and component specifications.
• Performs data analysis using statistical tools, regression analyses and develop transfer functions.
• Collects, records, reports, interprets and analyzes data, presents results to peers and business leadership.
• Provides advanced engineering skills and product evaluation support to the platform toward building business cases for new opportunities.

• 7+ year experience in R&D/Product Development Engineering.
• Medical Device experience with all aspects of Design Controls (FDA 21 CFR 820.30 / ISO 13485).
• Proficiency with fixture design including basic machining considerations and developing test methods.
• Understanding of Measurement Systems Analysis (MSA) and DFSS (design for six sigma).
• Experience with Minitab for Statistical Analysis.
• Proficiency in CAD, Pro/E, Solid Works.

• Previous Client experience.
• Orthopaedic Med Device specific experience (Stryker, Client, Client Biomet, Healthcare).