VP of Product Development

Found in: Appcast Linkedin GBL C2 - 2 weeks ago


San Diego, United States Armonica Technologies. Inc. Full time

VP of Product Development


We are searching for a Vice President product development executive to lead us through the commercial launch of our game-changing optical sequencing technology. We are looking for a disruptive leader with a background in MedTech, molecular diagnostics, or genomics sequencing to be part of the next game-changing company.



  • Product Development: Lead development efforts to provide solutions to product development tasks to meet performance requirements. This entails nanofluidics, semiconductor fabrication, DNA manipulation for use in sequencing, and optical technologies for low-light-level detection in microscopic imaging systems. Establish and implement data deliverables for product validation, regulatory compliance, and marketing needs.
  • Technical Expertise: Understanding of medical device/diagnostics product development under the QSR process. Understanding of micro/ nanofluidics for manipulation and delivery of long-strand DNA. Deep knowledge of physical and optical phenomena associated with sequencing technologies.
  • Cross-functional Collaboration: Ability to provide leadership relationships with other departments such as research and development, quality systems, regulatory/clinical affairs, and manufacturing.
  • External resources: Identify and direct outside engineering resources.
  • Regulatory Compliance: Knowledge of relevant regulations and standards, ensuring compliance with applicable FDA, ISO, and other regulatory requirements throughout the company development.
  • Intellectual Property: Participate in generating and expanding the IP portfolio.
  • Interact with other senior managers And the Board of Directors. Participate in fundraising.

 

 

Requirements

Education: Ph.D. in related engineering/physics discipline

Experience: 15+ years of experience in medical device and molecular diagnostics.


  • Demonstrated ability to provide strong leadership and strategic direction in developing and implementing a medical device engineering program.
  • Experience with obtaining regulatory approvals in the US and Europe
  • Experience participating in and delivering clinical studies to demonstrate product function, regulatory approvals, and marketing materials.
  • Demonstrated success leading cross-functional teams to drive innovation and deliver high-quality products within regulatory and compliance frameworks.
  • Proven track record of navigating complex regulatory landscapes and ensuring compliance with relevant industry standards and regulations, such as FDA requirements (e.g., 21 CFR Part 820), ISO 13485, and IEC 60601. Expertise in establishing robust quality systems and leading successful regulatory submissions.
  • Extensive knowledge and hands-on experience managing the entire product development life cycle, from concept ideation and prototyping to verification, validation, and commercialization. Proven ability to drive projects through milestones, meet critical timelines, and deliver products on schedule and within budget.
  • Skilled at attracting, developing, and retaining top engineering talent. Proven ability to inspire and motivate teams, foster a culture of innovation and excellence, and provide mentorship and guidance to facilitate professional growth.


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