Lucira Health
  • Emeryville, CA, USA
  • Full Time

About Lucira Health

Lucira Health is a medical technology company focused on the development and commercialization of transformative infectious disease test kits. We have developed a testing platform that produces centralized-laboratory-accurate molecular testing in a a single-use and consumer friendly test kit that is powered by two AA batteries and fits in the palm of a hand. Our LUCIRA Check It (OTC) and LUCIRA COVID-19 All-In-One Test Kit (Rx) are designed to provide a clinically relevant COVID-19 result within 30 minutes from sample collection.

Location

Emeryville, CA

Summary

The VP of Product Development will lead a cross-functional team to develop products to expand Lucira Health's diagnostic pipeline. This position involves product development leadership, technical contribution, partner selection and integration across the technical teams, ensuring the development and implementation of efficient operations and cost-effective systems to meet current and future needs of the company.

Responsibilities

  • Oversee the preparation and approval of the Product Requirement Document (PRD) as a response to the Product Market Requirements Document (MRD)
  • Lead the product development process to deliver products on time within budget meeting /exceed the agreed open PRD
  • Lead the project management, mechanical, electrical firmware and assay integration teams
  • Collaborate with the company's executive leadership to develop and meet organizational goals and strategic direction
  • Establish and implement the strategic direction of the company's product development initiatives, maintain the product roadmap
  • Execute within the appropriate FDA and regulatory framework
  • Ensure ISO 13485 compliance and certification
  • Build, coach and mentor teams to design, develop, and validate Lucira Health's products
  • Oversee the preparation and approval of the development of product development plans, including defining milestones, schedules and resources.
  • Oversee resource management, including equipment, facilities as well as hiring and developing the team, in line with business objectives.
  • Identify, recommend, and implement new technologies and systems to improve organizational processes and decision-making
  • Collaborate with Research on new technology integration into the product roadmap
  • Identify and vet external service providers, and consultants
  • Work with Operations in the selection of suppliers and components
  • Own the technical evaluation, recommendation, validation and implementation
  • Oversee the preparation of and approve product Design History File (DHF) and Device Master Record (DMR)
  • Present periodic updates to the company and Board of Directors
  • Contribute to facilities planning and capital equipment decisions
  • Assist with planning company growth, culture and strategy
  • Present to business partners, investors, and clinical collaborators
  • Maintain knowledge of emerging technologies and trends in product development related to the diagnostics industry

Qualifications

  • Bachelor's in Mechanical or Biomedical Engineering; Master degree preferred
  • 20+ years medical device industry experience; minimum 12-years of leadership experience at the director level or above
  • Demonstrated expertise in direct management
  • Proven track record in the delivery of complex high volume products to the market
  • Demonstrated an exceptional track record of product development of novel medical device technologies by partnering with research to bring new technology to market
  • Demonstrated a strong ability to lead and work within a cross-disciplinary team
  • Conversant in the following fields: biomedical and mechanical engineering, electrical and software engineering, materials and chemical engineering, molecular biology, chemistry, and manufacturing
  • Experience with CAD, rapid prototyping, statistical methods for analyzing experimental data, quality systems, and common manufacturing techniques is required.

Lucira Health is an equal opportunity employer and is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status or any other consideration made unlawful by federal, state, or local law.

Lucira Health
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