Manuel Orosco

About Manuel Orosco

I’m a data-driven medical device leader focused on turning complexity into scalable, compliant solutions, and delivering high-impact products to market.My journey began at the Alfred Mann Institute, where I collaborated across disciplines to develop medical devices that address critical unmet needs. That experience solidified my industry career ambitions and propelled me into a Senior Scientist role at NanoMR (now DNA Electronics) where I built foundational expertise in GMP and ISO 13485 compliance. Moving into management roles at DNA Electronics taught me that my greatest impact comes from empowering cross-functional teams to deliver tangible results and not individual contribution. What I am known for:Streamlined NPI from Concept to MarketLed 57 design-transfer processes from feasibility through pilot production both in-house and with CMOs.Simplification with ComplianceReduced product/process complexity and cost through Design for Excellence (DfX) initiatives, while ensuring alignment of product requirements and business goals.Cross‑Functional LeadershipStrategic alignment of R&D, Manufacturing, Quality and Regulatory, Operations teams based on competency and capacity to ensure on-time, compliant delivery. Empowering teams through active listening, coaching capability, and handing ownership to technical leads.Risk-Based MindsetImplemented risk management strategies at every stage of design and development by applying FMEA, root cause analysis, 5-Whys, etc. to safeguard product quality.Director‑Ready Experience Includes:• 14+ years in medical device and IVD, navigating both R&D and GMP manufacturing.• In depth experience scale-up, tech transfer, and GMP process implementation of reagents and cartridge consumables.Let’s talk if you are producing medical device, biotech, or pharma products that require strategic oversight, cross-functional leadership, and process development expertise. I’d love to connect on director-level opportunities.

Experience

1. Sr Manager

   Dna Electronics Dnae

   Sep 2021 — Present · Carlsbad, CA, US

   Drove cross-functional workflow optimization, reducing steps by 40% and per-kit costs by 85% through DOE and statistical process control (SPC).• Managed a 9-person team with 4 direct reports; advanced talent through cross-training, certifications, and tailored development plans aligned with company goals.• Led design and process FMEAs, coaching engineers on risk assessment; resolved a critical contamination issue by implementing controls that reduced bioburden by 96%, enabled LOD claims, and supported investment milestones.• Replaced manual document creation with PowerApps automation, integrating Office365, Greenlight Guru, and Egnyte; reduced work order creation time from 40 to 1 minute and improved visibility across pre-production workflows.• Managed sourcing for 400+ components across 26 suppliers; de-risked single-source enzymes by qualifying two alternate suppliers, improving shelf life, and reducing scrap costs.• Owned 5 design control processes and authored 30+ plans across validation and manufacturing; collaborated with QA/RA to align QMS documents with operations, improving training and reducing nonconformities.• Directed design transfer of cartridge assembly to a new CMO; resolved incomplete requirements and specifications through updated risk mitigation processes, increasing yield from 60% to 90% and reducing cycle time by 75%.• Developed a $5M facility upgrade plan to enable V&V and manufacturing continuity, expanding capacity for product scale-up; addressed facility control gaps impacting compliance, throughput, and quality.• Built real-time PowerBI dashboards tracking cycle time, yield, and DMR progress; used KPI trends to justify headcount increases and improve resource allocation.• Streamlined alignment of project plans across QA/RA, R&D, Engineering, and Finance using MS Project and RACI frameworks; improved clarity of deliverables and reduced variance in CapEx/OPEX budgets.

Education

• UC San Diego

  PhD, Chemistry

  2004 — 2009

• University of California, Riverside

  Biochemistry, Biology

  2000 — 2004

• UC San Diego

  M.S, Chemistry

  2004 — 2006

Skills

• Electrochemistry
• Characterization
• Spectroscopy
• R&D
• Chemical Synthesis
• Enzyme Kinetics
• Nanoparticles
• Drug Delivery
• Medical Devices
• Medical Diagnostics
• Nanotechnology
• Lifesciences
• Chemistry
• Polymers
• Nanomaterials
• Protein Chemistry
• Biosensors
• Polymerization
• Bioconjugate Chemistry
• Surface Chemistry
• Afm
• Microscopy
• Uv/Vis