Fluxergy · 8 hours ago
Director of Immunoassay Development
Irvine, California
Full-time
Onsite
Director/Executive
$170K/yr - $195K/yr
10+ years expFluxergy is a rapidly growing in vitro diagnostics company innovating on the cutting-edge of laboratory testing. As the Director of Immunoassay Development, you will lead the transformation of innovative assay concepts into robust, scalable, and regulatory-compliant diagnostic products that advance patient care.
BiotechnologyHealth CareHealth DiagnosticsMedicalMedical Device
Responsibilities
Lead the full immunoassay development lifecycle from early concept and feasibility to design transfer, verification, validation, and regulatory submission
Transform scientific innovation into impact by translating early proof-of-concept studies into structured design inputs, specifications, and controlled development plans aligned with FDA, ISO 13485, and CE-IVD requirements
Design and oversee meaningful experiments that generate high-quality data for regulatory submissions, ensuring traceability and alignment between design inputs, verification, and validation outcomes
Collaborate seamlessly with Regulatory Affairs and Quality teams to ensure experimental design, documentation, and testing strategies meet FDA 21 CFR 820 and IVDR standards
Partner cross-functionally with Manufacturing, Process Engineering, and Operations to refine assay transfer protocols that drive robustness, scalability, and cost-effectiveness in production
Oversee design verification and validation (V&V) activities including method comparison, reproducibility, precision, interference, and stability studies — ensuring data integrity and regulatory readiness
Drive design transfer to manufacturing, supporting process qualification, equipment validation, and training to enable smooth transition into production
Mentor and empower a multidisciplinary team of scientists and engineers, fostering a culture rooted in collaboration, scientific rigor, and continuous learning
Work strategically with Program Management to define project timelines, resource plans, and risk mitigation strategies that align with company milestones and product launch goals
Review and approve technical documentation, design history files, verification reports, and regulatory submissions (e.g., 510(k), De Novo, CE-IVD) with a commitment to excellence and compliance
Stay future-focused by keeping current with evolving FDA and IVDR guidance, and by evaluating emerging immunoassay technologies that strengthen innovation and competitiveness
Qualification
Required
Ph.D. in Biochemistry, Immunology, Analytical Chemistry, or related discipline with a strong foundation in immunoassay principles
10+ years of industry experience in immunoassay or in vitro diagnostic (IVD) product development within a regulated design control environment
Proven track record of translating benchtop assays (e.g., ELISA, CLIA, LFA, bead-based, or homogeneous immunoassays) into validated, manufacturable diagnostic products
Comprehensive understanding of FDA 21 CFR 820, ISO 13485, IVDR, and design control processes — including risk management, verification, validation, and design transfer
Demonstrated success in verification and validation planning, data analysis, and preparation of high-quality data packages for regulatory submissions
Hands-on collaboration experience with manufacturing and process engineering teams to scale production and ensure consistency across lots
Inclusive and results-oriented leadership style, with the ability to guide teams, balance priorities, and deliver products that meet technical and regulatory milestones
Excellent communication and collaboration skills, with the ability to connect scientific, regulatory, and business goals across diverse teams and stakeholders
Benefits
Excellent Medical/Dental Benefits
99% medical benefit premiums paid by Fluxergy and covers employee, partner, and dependents
100% dental and vision premiums paid for employee, partner, and dependents
100% Life Insurance premiums paid for the employee
Work - Life Balance Minded Time Off
15 paid vacation days
2-week paid winter break
7 company paid holidays
5 paid sick days
A Work Culture Which Believes in Promoting from Within
Wear lots of hats / accelerate your career growth!
We are a flat organization by design – lots of visibility!
Many of our current leaders started their career with Fluxergy!
Company
Fluxergy
Fluxergy is a biotechnology company that offers point-of-care testing, PCR, and medical diagnostics.
51-200 employees
H1B Sponsorship
Fluxergy has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (2)
2023 (6)
2022 (3)
2021 (2)
Funding
Current Stage
Growth StageTotal Funding
$49.95M2020-05-13Series C· $30M
2017-10-24Series B· $15M
2015-04-08Series A· $4.5M
Leadership Team
Ryan Revilla
Vice President
Tej Patel
President
Recent News
Google Patent
2025-05-04
Google Patent
2025-02-08
Company data provided by crunchbase