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Vice President of Engineering Leadership

2 months ago

Waltham, Massachusetts, United States InnoTech Staffing Full time
Job Overview

InnoTECH Staffing is seeking a Vice President of Hardware Engineering and Program Management for a pioneering company in the in-vitro diagnostics sector.

The organization is evolving from research and development to market introduction and requires a seasoned leader in Hardware Engineering with a robust background in product development from ideation to market launch. The ideal candidate will possess expertise in leadership, electronics, software, fluidics instrumentation, product lifecycle management, systems integration, contract manufacturing, and successful IVD system development and commercialization.


Key Responsibilities:
  • Lead and cultivate high-performing teams in a dynamic, rapidly growing environment, including responsibilities for recruitment, onboarding, goal setting, performance enhancement, and accountability.
  • Utilize extensive knowledge of principles and best practices in hardware, software, fluidics, optics, system integration, consumable design, and manufacturing.
  • Establish and maintain partnerships with strategic product collaborators, including suppliers, contractors, and commercial partners.
  • Collaborate with internal and external teams to provide support and guidance for consumable and instrument-related challenges.
  • Implement and uphold scientific, engineering, and analytical best practices to achieve objectives.
  • Conduct thorough technical and design reviews, assessing and approving design modifications to meet customer and internal specifications.
  • Drive process enhancements for optimal resource utilization and adherence to quality and regulatory standards.
  • Foster a collaborative environment to ensure effective teamwork between engineering teams and other departments.

Oversight Responsibilities:
  • Plan, oversee, and evaluate experimental designs, design concepts, documentation, and technical outputs.
  • Proactively identify potential issues affecting system performance and lead the development of risk mitigation strategies.
  • Facilitate the identification of solutions to intricate technical challenges through root cause analysis and propose relevant design adjustments.
  • Manage resource allocation and respond promptly to shifting business priorities.
  • Prepare regular reports, presentations, and other materials to communicate program progress and support business initiatives.

Qualifications:
  • Bachelor's degree in engineering is mandatory.
  • A minimum of 15 years of experience in product development, with at least 3 years in a leadership capacity.
  • Five or more years of experience in the development of regulated medical devices.
  • Proven experience in successful IVD system development and market introduction.
  • Strong understanding of both reagents and instrument platforms, as well as assay integration.
  • Familiarity with IVD regulatory standards, including CE, FDA, and CLIA.
  • Experience in post-launch product support with a focus on reliability design, testing, and monitoring.
  • Robust analytical skills and knowledge of system troubleshooting methodologies.

Essential Skills:
  • Exceptional communication skills, capable of effectively conveying information within and outside the organization.
  • Strong organizational abilities and a knack for resolving ambiguous challenges.
  • Excellent project planning and management capabilities.
  • Able to operate under tight deadlines without compromising quality and discipline.

InnoTECH Staffing represents a forward-thinking in vitro diagnostics company that has developed an integrated IVD platform for a wide range of blood and urine tests. The platform employs a patented hybrid hardware architecture, fluidics, and optoelectronic technologies to deliver comprehensive diagnostic information at the point of care.