Derick Miller Email & Phone Number

Thousand Oaks, Ca, Us

Thousand Oaks, Ca, Us

Supported combination product development team through stage/gate development. Worked closely with cross-functional teams to develop detailed engineering specifications and documentation, as well as supported verification, validation, and regulatory submissions. Ensured compliance with international and domestic regulations and internal SOP’s. ❖ Executed verification testing and documentation per plan and on schedule.❖ Developed and/or reviewed design documents, development/verification/validation plans, specifications, and other essential documentation for combination product projects.❖ Integrated combination product project documentation into DOORS requirements management database.

West Lafayette, Indiana, Us

Provided technical engineering expertise for product development in the Hernia / Dura product management team. Led product teams through stage/gate development. Worked closely with cross-functional teams to manage new products and prototypes through clinical bench-top and animal studies. Produced technical documentation and ensured compliance with international and domestic regulations. Investigated product complaints. Led a team of three R&D engineers. Completed root cause analysis, Corrective and Preventive Actions (CAPA), and manufacturing cost analysis. Managed the development pathway. Coordinated in-vivo testing for a drug-eluting device for soft tissue repair.❖ Led Hernia / Dura product development activities, accounting for 50% of Cook Biotech sales.❖ Delivered the first synthetic-biologic combination hernia repair device on the market.❖ Successfully updated the hernia product line, penetrating the hiatal hernia market.❖ Enhanced hernia product acceptance in the U.S. and overseas.❖ Acted as a technical resource within the OR during new product introductions.❖ Presented technical recommendations to senior executives.

West Lafayette, Indiana, Us

Managed development projects and developed test protocols. Performed V&V and risk management activities. Completed bench testing, reporting, and DHF documentation. ❖ Developed three new products and ensured compliance with ISO and CFR regulations.

Us

Analyzed surface chemistry uniformity of disks using atomic force microscopy. Worked closely with teams to improve interferometric (label-free) detection limits and troubleshot the microarray diagnostic system. Designed novel immunoassay systems. Analyzed silanized three-dimensional surfaces. ❖ Improved interferometric / fluorescent assay detection limits by several orders of magnitude.❖ Identified biologic and electronic noise sources and developed novel assay formats.❖ Optimized systems for diagnostic products, improving detection limits.❖ Improved processes to enhance throughput / multiplexability and reduce cross-contamination.❖ Adapted screen printing technology and developed a novel thixotropic super-hydrophobic polymer, creating barriers to reducing sample containment failures and cross-contamination.

Us

Used atomic force microscopy (AFM) to analyze protein microarray spot uniformity, silicon surface consistency, and IgG aggregation. Developed correlations between AFM and interferometry.

West Lafayette, In, Us

- Characterized nano-scale polymeric vascular biomaterials using atomic force microscopy(AFM), scanning electron microscopy, and ESCA- Evaluated protein adsorption and conformation on various polymer films utilizing SDS-PAGE, western blotting, atomic force microscopy, and ELISA - Designed and conducted experiments in order to evaluate in-vitro vascular cell function on a variety of nano-scale polymer films- Patented process for creating novel nano-structured polymer films- Trained undergraduate research assistants in laboratory procedures and cell culture- Authored seven peer-reviewed journal publications including five on vascular biomaterials

Us

Offered technical CAD mechanical design services to clients in the defense, aerospace, electronics, and medical device sectors. Created and revised 3D CAD models and technical drawings, including GD&T.❖ Completed mechanical designs for precision high speed ultrasonic bonders, precision laser alignment equipment, tooling for fuel cell components / stents, and injection molded parts.

Doctor Of Philosophy (Ph.D.), Biomedical/Medical Engineering

Master Of Science (M.S.), Biomedical/Medical Engineering

Bachelor Of Science (B.S.), Mechanical Engineering