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)