Vice President of Engineering Leadership

2 weeks 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 field of in-vitro diagnostics.

The organization is evolving from research and development to market introduction and requires a seasoned leader in Hardware Engineering with extensive experience in product development from inception to market launch. The ideal candidate will possess a strong background in leadership, electrical and mechanical engineering, software, fluidics instrumentation, product lifecycle management, systems integration, contract manufacturing, and analytical capabilities.


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

Oversight and Planning:
  • Supervise 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 resolution of complex technical challenges through root cause analysis and propose design modifications as necessary.
  • Manage resource allocation and respond promptly to shifting business priorities.
  • Prepare regular reports, presentations, and supporting materials to communicate program progress and support business initiatives.

Qualifications:
  • Bachelor's degree in engineering is required.
  • A minimum of 15 years of experience in product development, including at least 3 years in a leadership capacity.
  • Five or more years of experience in the development of regulated medical devices.
  • Proven track record 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 troubleshooting methodologies.

Essential Skills:
  • Exceptional communication skills, with the ability to convey information effectively within and outside the organization.
  • Strong organizational abilities and a knack for resolving ambiguous challenges.
  • Excellent project management and planning capabilities.
  • Ability to work 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 diverse range of blood and urine tests. This innovative platform leverages a patented hybrid hardware architecture, fluidics, and optoelectronic technologies to provide comprehensive diagnostic information at the point of care.

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