Senior R&D Engineer

Role Overview

• Develop life-saving medical device products for spine surgery
• Collaborate with a team to lead new product development; developing and designing implants, instruments, and systems; conducting product and use testing; and managing system interfaces
• Actively seek out Voice of the Customer (VOC) input and translate that 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
• 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 and apply feedback to improve designs
• Optimizes designs by designing and conducting relevant tests, experiments, and evaluations, including numerical verification
• Defines and performs verification and validation activities, ensuring products meet user needs, system requirements, and intended use
• Writes engineering reports and creates presentations as required to document and communicate results
• Contributes and builds domain knowledge around spinal systems, their clinical use and application via customer and field visits, pre-clinical in vivo labs, literature searches, and training
• Documents tradeoffs, rationales, and potential solutions

Requirements

• Bachelor’s degree in engineering or a technical-related degree – Mechanical Engineering preferred
• 4+ years of engineering design and development experience with 2+ years of medical device experience
• in spine, trauma, orthopedics, or dental
• An MS degree in engineering is preferred.
• 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.
• Working knowledge of other disciplines.
• 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)