Senior R&D Engineer

Role Overview

• Develop life-saving medical device products for spine surgery
• Collaborate with a team to lead new product development
• Develop and design implants, instruments, and systems
• Conduct product and use testing
• Manage system interfaces
• Actively seek out Voice of the Customer (VOC) input
• Translate VOC into product requirements, design specifications, and mechanical concepts
• Work under general direction and may serve as a key functional core team member or as an engineer on an extended team
• Plans and implements all aspects of multiple simultaneous designs and the development of new medical device products from initial design through market release, in accordance with agreed project timelines and NPI Development processes
• Defines medium to high complexity spinal systems and conceptualizes designs that meet the needs and uses of the customer, regulatory agencies, and the business
• Provides technical leadership in defining, evaluating, and mitigating system design risks
• Engages with customers (internal and external) to understand and prioritize their needs
• Optimize designs by designing and conducting relevant tests, experiments, and evaluations
• Defines and performs verification and validation activities
• Writes engineering reports and creates presentations to document and communicate results
• Contributes and builds domain knowledge around spinal systems
• Supports documentation throughout all phases of research and development
• Investigates and evaluates existing technologies
• Provides training and mentorship to less experienced team members

Requirements

• Bachelor’s degree in engineering or a technical-related degree – Mechanical Engineering preferred
• 4+ years of engineering design and development experience
• 2+ years of medical device experience
• in spine, trauma, orthopedics, or dental
• Clinical knowledge for the use of products
• Knowledge of spinal anatomy relative to surgical procedures
• Experience in the use of systems engineering methodologies, including requirements development, analysis, allocation, review, tracing, and verification/validation
• Ability to effectively communicate and work collaboratively with others as a member of a team
• In-depth knowledge and wide application of technical principles, theories, and concepts in the related field of expertise to develop innovative approaches to work
• Knowledge of manufacturing processes, including machining and 3D printing
• Understanding of the spinal medical device industry and competitor products.
• Proven proficiency with CREO, SolidWorks, or similar 3D CAD program
• Mastery of engineering drawing standards, including GD&T and tolerance stacks
• Demonstrated track record of successful designs of surgical instruments (Spinal instruments are a plus)
• Knowledge of Agile and Windchill
• Demonstrated ability to take initiative in keeping current with technology developments in a specialized area
• Experience working in an FDA-regulated and/or medical device environment with ISO and Quality System Regulation requirements

Benefits

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)