Salary: Up to $100K depending on specific experience + 10% Bonus & Full benefits when eligible
Reports To: Director of R&D
Responsible largely for the development of new products and the evaluation and improvement of existing products, including but not limited to; creating designs, using 3D CAD to model and produce drafts, assisting in the development processes across manufacturing, QC, regulatory affairs, and project planning for any assignments the successful candidate would be leading.
• Research, develop, and design spinal implants and instrumentation including both New Product Development as well as the upkeep of current systems
• Leading the provision of complete project deliverables independently and in a timely manner
• Continual improvements in quality and higher-value services
• Indepdnently lead the whole development process from concept design, supplier selection, testing, design finalization, product verification and validation, and finally to transfer and launch troubleshooting
• Manage vendor and stakeholder partnerships
• Communicate across a range of cross-functional teams and disciplines so that all involved parties are constantly appraised of upcoming deadlines and challenges
• Use of SolidWorks to create detailed drawings and designs
• Stress-testing (static and fatigue) on New Product Designs using FEA
• Manage system Design History files and the associated documentation
• Provide support and technical expertise to other teams within the organization (e.g. sales, purchasing, regulatory, marketing, customer service, senior management)
• Share industry knowledge and expertise with other Group Staff
• Uphold the organizational and group guidelines, procedures, and protocols of the company
QUALIFICATIONS & EXPERIENCE
• BS in Mechanical Engineering or Biomedical Engineering essential
• At least 5 years of industry experience essential
• CAD experience essential (SolidWorks preferred)
• Spine/Orthopedic Implant design experience essential.
• Experience of the Product Development cycle and phased approach
• In-depth knowledge of manufacturing processes and common materials/practices in the medical device industry
• Experience of GD&T, stack-up analysis, and mechanical testing
• Experience and knowledge of ASTM, ISO, FDA standards, regulations, and guidelines
• Independence and responsibility for a team
• Able to effectively track and complete multiple tasks whilst adhering to scheduling
• Able to effectively disseminate information to management, surgeons, and field personnel as required (PowerPoint skills preferred)
• Project Management planning experience preferred (MS Project, Smartsheet, etc.)
To carry out the requirements of the role, the successful candidate will be required to: sit and talk/hear, stand, walk, use hands and digits to handle, assess, feel, and reach, and be capable of lifting up to 25lbs of weight.
NB: Reasonable provisions may be made to enable candidates with disabilities to carry out required tasks.
Candidates will largely be working in an office-style environment with a moderate noise level.