VP, Head of Engineering / Program Management - In Vitro Diagnostics
- Job Title
- VP, Head of Engineering / Program Management - In Vitro Diagnostics
- Job ID
- 27706265
- Location
- Waltham, MA 02451
- Other Location
- Description
-
InnoTECH Staffing is looking to hire a VP, Hardware Engineering / Program Management for an in-vitro diagnostics company in Waltham, MA.
The company is transitioning from R&D to commercialization and needs an experienced Head of Hardware Engineering who has a background in product development from concept to launch, leadership, E/M, software and fluidics instrumentation, product lifecycle management, systems integration, contract manufacturing, successful IVD system development and commercialization and analytical skills.
Summary:
The Vice President, Engineering / Program Management is responsible for leading the consumable, software and instrument engineering programs. The candidate will formulate and lead the company’s product development strategy and ensure efficient execution of the related programs. Success in this role will stem from a strong knowledge of the engineering, science and regulatory environments related to in vitro diagnostics and the ability to analyze data to manage product development and innovation. Additionally, experience driving high complexity projects through completion is critical. Due to the level of complexity of IVD platforms and the nature of startup environments, the candidate must have excellent organizations skills, the ability to adapt quickly and eagerness to use a hands-on approach to support troubleshooting and problem solving
Responsibilities:
• Build and lead effective teams in a fast-paced, high growth environment including hiring, on-boarding, goal setting, performance improvement and accountability
• Apply broad knowledge of principles and best practices in hardware, software, fluidics, optics, system integration, consumable design and manufacturing
• Develop and maintain relationships with strategic product partners including suppliers, contractors and commercial partners (CMOs)
• Interface with internal and external teams to provide support and guidance for consumable and instrument related issues
• Ensure fact-based scientific, engineering and analytical best practices and principles are implemented and utilized to accomplish tasks
• Ensure effective technical and design reviews, evaluate and approve design changes to ensure customer and internal requirements are met
• Drive process improvements for efficient utilization of resources and compliance with quality and regulatory requirements
• Create an open environment and promote teamwork across the organization to ensure strong collaboration between the engineering teams and other functional areas
• Oversee, plan, and review: experimental designs, design concepts, documentation, and technical output
• Anticipate potential problems that may impact system performance and drive the development and implementation of risk mitigation plans
• Lead identification of solutions to complex technical issues by root cause analysis procedure and propose potential design modifications as they pertain to system and assay performance
• Manage resource planning and respond with appropriate sense of urgency to changing business priorities
• Develop regular reports, presentation and other support materials to communicate program status and support business activities
Requirements:
• Bachelors degree in engineering required
• 15+ years of experience in product development with at least 3 years in a successful leadership role
• Five or more years of experience in regulated medical device development
• Experience with successful IVD system development and commercialization
• Strong familiarity with both reagents and instrument platforms and assay integration
• Familiarity with IVD regulatory requirements including CE, FDA and CLIA
• Experience with post-launch product support with emphasis on reliability design, testing, and tracking
• Solid analytical skills and knowledge of system trouble-shooting methodologies
• Skilled in analytical hardware development with specific experience in:
o Optical and electrical analytical technologies
o Fluidic systems
o Assay processing (aliquoting, incubation, signal processing)
o System integration
o System verification and test protocol creation
General Skills:
• Strong communicator with the ability to communicate effectively within and outside of the company
• Strong organizational skills and ability to solve ambiguous problems
• Excellent project planning and management skills
• Ability to work on aggressive schedules while not sacrificing discipline and quality
Our client was founded in 2013, and is an innovative in vitro diagnostics company that has developed a fully integrated IVD platform for performing a growing array of blood and urine tests. The platform uses a patented hybrid hardware architecture, fluidics, and optoelectronic technologies to go beyond test results and deliver complete diagnostic information sets at the point of care.
In 2015, the company received the Partners Healthcare Innovations Award for high impact emerging technologies and was the first company to receive a direct investment from the Massachusetts General Hospital. In 2018, the company entered into a multimillion dollar supply agreement with a leading global animal health company with a goal of launching a veterinary use product in 2023.
Compensation includes base salary, bonus, equity and full benefits
