Our client, an innovator in 3D printed implants and instrumentation, has an immediate need for a Senior Mechanical Engineer (SME) with experience in the orthopedic industry. This position will join the engineering team and be expected to lead a segment of the company's product development efforts in technically advanced product categories.

The SME will report to the CTO and be a part of the engineering team. As a leader in the engineering team, the person in this role is expected to semi-autonomously manage product development activities for their product lines.

Responsibilities:

• Concept design and diverse concept iteration on both novel implant ideas and implants to serve existing market segments.
• Collaborate with surgeons on design feedback and clinical considerations.
• Independently manage product development efforts for a product line including project planning, working to budgets, order management, testing management, 510(k) submission support, launch planning support, and sustaining engineering activities.
• Work on instrumentation and implant product line extensions.
• Drafting and technical review of engineering drawings.
• Partner with manufacturers on DFM optimizations.
• Conduct tolerance analysis for complex instruments and implant assemblies.
• Partner with the quality team to produce QMS documentation of designs.
• Plan and execute the product side of labs for clinical evaluation of implants and instruments.

Preferred Education and Experience:

• 5+ Years in spine product development
• B.S. or Higher in mechanical or biomedical engineering from and ABET accredited institution.
• Strong Solidworks skills in both modeling and drafting.
• Excellent knowledge in the application of GD&T, two dimension, and multi dimension tolerance analysis.
• Applied knowledge of medical device failure modes and risk analysis.
• Strong analytical, critical thinking, and interpersonal communication skills.
• Ability to prioritize projects, take initiative, conduct research, and digest large quantities of information.
• Collaborative interpersonal work style, with the ability to work interdependently from a larger project plan.