Darin Mcdaniel Email & Phone Number

Tucson, Arizona, United States

Ettlingen, Baden-Württemberg, De

San Diego, California, Us

In a company with a recently launched NGS (next-generation sequencing) instrument, I led the transition from engineering-led assembly, test and shipping of the first few units to an independent, well-documented, quality-minded production organization, which produced 50+ units during my tenure. Company reorganization in June 2024 brought an end to these efforts.

Morrisville, North Carolina, Us

In an early-phase startup, I co-led the engineering development of an instrument platform in the digital polymerase chain reaction (dPCR) space, while laying groundwork for transfer to Operations. To this end, I coached the engineering team in design-for-manufacturability, while leading the planning and budgeting for in-house manufacturing of both the instrument and its consumable stream. Company reorganization in December 2022 brought an end to these efforts.

Tucson, Az, Us

Over the course of my 9-year career at Accelerate, I excelled in the following roles:• Head of Instrument Manufacturing. I established the Enterprise Resource Planning infrastructure for, then oversaw production of, our initial launch platform, the Accelerate Pheno™. I organized production lines according to Lean Manufacturing principles and FDA good manufacturing practices, tied together via fully electronic Device History Records and manufacturing work instructions. To date, more than 1000 Pheno™ modules have been produced, with mean time between repair visits of more than 1 year.• Head of Fulfillment Operations. As Accelerate grew, two responsibilities were added to my portfolio: Supply Chain and Kit Pack (final kitting/packaging of customer assay kits). As part of my Supply Chain responsibilities, I revamped Accelerate’s Supplier Quality program. In Kit Pack, I introduced a barcode-driven real-time labeling system elegantly combining Lean Manufacturing and FDA/ISO label control. For both areas, I introduced visual management to material inventory, to clarify its quality release status.• Head of Operations. For my last 3 years at AXDX, I led the entire Operations organization, with ~40 direct/indirect reports – adding Consumable Manufacturing, Quality Control and Design Transfer to my portfolio. I rewrote Key Performance Indicators for all areas to align all Ops teams in the same direction for building current products, while coaching Design Transfer in manufacturability of next-gen products. To date, more than 350,000 PhenoTest™ kits have been produced and shipped to customers worldwide.

Tucson, Arizona, Us

Over the course of my 20-year career at Ventana, I excelled in the following roles:• Senior R&D engineer. During company’s start-up phase, I was responsible for mechanical engineering design and development of three major instrument product lines, including the company's then-flagship instrument. For this role, I concentrated on component design, heat transfer; and transfer to production.• Integration manager. As Ventana grew to the point of acquiring another company in a related field (tissue processors), I was responsible for leading integration efforts at the new subsidiary.• Quality engineering manager. As the company’s portfolio began to grow, I was responsible for a team whose charter was to track, investigate and correct instrument field issues. In this role, I re-wrote all the company’s Corrective and Preventive Action (CAPA) procedures. • Manufacturing engineering manager. As the company matured and focused on techniques for production efficiency, my team’s charter grew to include manufacturing engineering. In this role, I worked to incorporate Lean Manufacturing principles into our production lines. During this time, I also led the operations aspect of the launch of the company’s first primary-staining instrument.• Design transfer manager. Concurrent with Ventana’s integration into Roche Diagnostics, I moved into a slightly different role – managing a group of four direct engineers and several contract engineers in the areas of: instrument design transfer from development; cost reduction of existing instrument products; re-design for obsolescence for existing instruments; and coordination of outsourcing of key assemblies.• Senior manufacturing manager. From there, I went on to lead the Advanced Staining – Instruments manufacturing group, with 25 direct/indirect reports. Our production lines were organized according to Lean Manufacturing principles and produced 100-120 in vitro diagnostic instruments per month.

Dulles, Va, Us

Launch vehicle manufacturer. Responsibilities included composite analysis and supersonic aerodynamics. Analyzed rocket motor exhaust flowfield to provide aerodynamic loads for structural analysis

Major gas turbine engine manufacturing company. Responsibilities included stress analysis, heat transfer, software design and fluid flow. Conversant with probabilistic design approaches and Taguchi experiment design. Applied research as principal investigator for state-of-the-art test programs into turbine-flowpath heat transfer/mixing. Co-designed and tested "transient temperature limiter", a portion of the T800 engine's ECU (engine control unit), which limits engine fuel flow based on calculated temperatures during accelerations.