Senior Mechanical Engineer
Southeast, -- US
Well-funded, disruptive, pre-revenue surgical company continues to expand in the Southeast US.
Join a growing engineering team to support the product development activities though the design, development, and manufacture of mechanical and electromechanical medical device systems for use in complex, computer assisted surgical procedures. You will be part of a program management team that will drive objectives with existing programs in the ongoing development to include MIS instrumentation with complex system which incorporates 3D HD cameras and endoscopic instrumentation development. Ideally, the successful candidate will have clear grasp on reconciling clinical, technical scenarios into real-life usage.
Position Responsibilities: (R&D Engineering)
- Design, develop, validate and build a highly complex electromechanical surgical systems improving on existing systems while developing NextGen platform and instrumentation.
- Translate platform needs into engineering requirements, reviewing test data while performing technical and functional risk analysis to uncover engineering and project risks.
- Perform and oversee the execution of verification and validation testing, plans, protocols and testing, writing clear technical summaries and data-driven technical summaries and reports.
- Determine if outside, contract services can be used cost effectively and expeditiously in place of in-house resources; recommend to management.
Position Responsibilities (Manufacturing Engineering)
- Oversee selection and qualification of vendors and contract service providers, including Contracts, SOW’s, assuring alignment with overall company strategy.
- Develop protocols, procedures, and reports necessary for comprehensive validation, and manage process validation for manufactured product and associated assembly equipment, test equipment, and processes at manufacturing partners, including DFT to qualified manufacturing partner.
- Train clinical support specialists in understanding design and operation of complex medical system
- Provide technical oversight and support to sustain production of products manufactured at remote locations including the resolution of supplier issues.
- Evaluate engineering change requests to determine effects on existing processes and that they are suitable and practical for manufacturing using your strong documentation skills.
- Identify opportunities for cost reduction. Implement process and product improvements to achieve cost reduction goals.
- Minimum BS in biomedical, electrical, manufacturing or mechanical engineering.
- 5+ years of engineering design and manufacturing experience in the medical device industry and experience in a clinical setting.
- Hands-on experience effectively resolving design, manufacturing processes, and vendor issues associated with tightly specified parts, component variability, and obsolescence.
- Familiarity with complex electromechanical systems and troubleshooting preferred
- Strong computing skills including Solidworks, MS Office Suite, MS Project or equivalent.
Compensation: Competitive, commensurate with education & experience
Direct Reports: High level individual contributor
Years of Experience: 5+
Degree: BS in Biomedical, Electrical, Manufacturing, or Mechanical Engineering.
Location: Southeast United States (limited relocation assistance available)
NOTE: This job description is confidential and not intended to be all-inclusive. Contact the recruiter below for more information.
Legacy MedSearch was named to the 2019 Forbes list of Best Recruiting Firms in America.
Arshad is a seasoned recruiter in the healthcare space with over 15 years of experience in promoting career growth for healthcare professionals. He has played a critical role in the launch of several startup companies. He is known for versatility and leadership; expert in overseeing high-level priorities and a broad range of responsibilities.