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.
- 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.