Siemens Healthineers · 1 day ago
Research & Technology Manager
Newark, DE
Full-time
Onsite
Director/Executive
$177K/yr - $244K/yr
10+ years expSiemens Healthineers is a leader in medical technology, pioneering breakthroughs in healthcare. The Research & Technology Manager will lead a multidisciplinary team focused on the development and commercialization of drug testing immunoassays, ensuring regulatory compliance and product excellence.
Health CareHealth DiagnosticsMedicalMedical Device
Responsibilities
Lead new product development (NPD) for immunoassays under FDA Design Control (21 CFR 820) and Siemens Healthineers quality systems while ensuring Product Delivery Excellence
Oversee assay development activities at the Glasgow, DE site and coordinate with other international R&D sites as needed, ensuring harmonized quality and documentation standards
Lead development and validation activities to meet US (FDA) and international (e.g., CE-IVDR, China NMPA, etc) regulatory requirements, ensuring global market readiness
Ensure all assays and supporting data packages meet the requirements for OEM supply agreements and seamless integration into third-party platforms
Lead the technical maintenance and enhancement of commercial products, managing complex change controls and providing high-level troubleshooting for manufacturing and quality issues (CAPA/NC) as needed
Work closely with our OEM-Out Business Team, negotiating technical specifications, managing deliverables, and ensuring successful implementation of Syva products with OEM customers
Act as the primary technical interface for strategic development partners, negotiating technical specifications, managing deliverables, and ensuring successful technology transfer for new and existing products
Champion Lean R&D principles to accelerate development cycles and increase efficiency within a regulated environment
Mentor and inspire teams to foster a culture of accountability, speed, scientific rigor, and collaboration across global R&D sites
Establish and track key performance indicators (KPIs) for the Syva assay development pipeline, providing actionable insights to executive leadership
Qualification
Required
Ph.D. in Chemistry, Biochemistry, Clinical Chemistry, or related field (or Bachelor's/Master's with significant relevant experience)
Minimum 10 years' progressive experience in immunoassay development within IVD or clinical diagnostics
At least 5 years' experience managing technical teams, including globally dispersed teams or external partners/OEMs
Proven track record in leading the development and launch of FDA-cleared/approved and CE-marked clinical immunoassays
Demonstrated success as a change agent in optimizing R&D processes and improving team culture
Preferred
Experience in drugs of abuse testing, toxicology, therapeutic drug monitoring, and validity testing preferred
Benefits
Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Long-term and short-term disability insurance
Paid parking/public transportation
Paid time off
Paid sick and safe time
Company
Siemens Healthineers
Siemens Healthineers is a healthcare technology company that provides diagnostic and therapeutic products and services. It is a sub-organization of Siemens.
10001+ employees
H1B Sponsorship
Siemens Healthineers 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 (104)
2024 (70)
2023 (64)
2022 (89)
2021 (50)
2020 (86)
Funding
Current Stage
Public CompanyTotal Funding
$2.76BKey Investors
Ontario Together Fund
2021-05-25Grant· $2.5M
2021-03-25Post Ipo Equity· $2.76B
2018-03-16IPO
Leadership Team
Enno Nehrbass
SVP / Head of Strategy Diagnostic Imaging
Sebastian Kronmueller
Vice President, Head of Strategy & Business Development - Laboratory Diagnostics
Recent News
South Africa Today
2026-01-07
2026-01-07
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