Miroculus provides miniaturized and automated sample-to-answer solutions for molecular diagnostics. We use a proprietary digital microfluidics (DMF) technology covered by 4 issued patents and 26 patent applications in 12 different families that enable running any nucleic acid testing protocol on a low cost cartridge.

Miroculus provides miniaturized and automated sample-to-answer solutions for molecular
diagnostics. We use a proprietary digital microfluidics (DMF) technology covered by 4 issued patents and 26 patent applications in 12 different families that enable running any nucleic acid testing protocol on a low cost cartridge.
One of the potential applications is a test for gastric cancer in symptomatic patients. The test’s high negative predictive value will enable physicians to safely avoid endoscopy for cancer-free patients, increasing cancer detection rate while reducing the total healthcare cost.

Two of the key differentiators of the Miroculus platform are automation (sample-to-answer) and
ease of use. This combination enables the execution of complex protocols without the need of skilled scientists or expensive equipment, thus making molecular diagnostics more affordable
and scalable than ever before.

Position Summary

This person leads the product development and execution of the Miroculus, end-to-end (sample-to-answer) instrument. This position is responsible for managing the product development staff while also serving as the lead interfacing between Miroculus and its external design and development partners and providers.

This person will work closely with other functional areas to translate customer requirements into appropriate product requirements and development plans; oversee quality management of the system hardware, software, firmware, assay and related aspects of its consumable products; coordinate projects in their scope, schedule, resources and budget; establish Design Control adherence during development; lead system integration activities; support the validation activities and eventual launch of the platform.

Experience with hardware, software and assay development life cycles, creating design inputs
and outputs, design verification and design validation.

Strong technical knowledge and hands-on experience with the tools and methods used in
system development and assay development are essential.

This individual must possess excellent communication, analytical and problem-solving skills while being adept at forming collaborative working relationships with internal and external team members.

Focus areas are within nucleic acid biomarkers.

Tasks and Responsibilities

  • Quality management and design control for all system engineering of Miroculus products
  • Plan and coordinate the creation of comprehensive hardware and software requirements, assay requirements and functional specifications that feed into the design and development of the system
  • Build current and future competitive advantage by understanding and addressing the needs and opportunities of our markets and customers
  • Build and lead a team that works collaboratively across a matrix organization to execute the portfolio, leveraging resources and support from R&D, marketing and sales
  • Represent the company and build relationships with engineering companies, manufacturing third parties and eventually distribution partners
  • Plan and coordinate the execution of appropriate design verification/validation testing
  • Play a strong role in development and maintenance of Quality System elements, specifically for Design Control.
  • Establish appropriate risk analysis activities which include the use of risk analysis tools and mitigation procedures

Preferred Experiential Background

  • Share a passion for our mission to improve human health by democratizing access to state of the art molecular diagnostics
  • 8+ years experience leading a diverse, experienced team developing life science or IVD systems following applicable regulatory guidelines
  • A background of senior leadership positions with organizations that have demonstrated significant growth in size and complexity
  • Demonstrated experience in taking conceptual research through development to a viable IVD platform for commercialization
  • “Been there, done that” experience for IVD product development from early stage development (innovation stage) to late stage development (product validation) required
  • Excellent communication skills, including verbal, written and presentation
  • Strong negotiation skills
  • Excellent program/project management skills – including scheduling, budgeting, resource management, etc.
  • Experience in microfluidics is strongly preferred

Preferred Educational Background

Graduate degree (MS or PhD) in Engineering/Science, or related field

Location

San Francisco

Applicants should send cover letter and resume to [email protected]

Miroculus believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.