My Experience - Devin Mack

ENQUAL’s experience reflects repeated responsibility at inspection-critical decision points—where design intent must be explained, risk ownership demonstrated, verification justified, and system behavior defended under regulatory scrutiny. This work spans development, remediation, and post-market sustainment for medical device and combination product organizations operating under FDA and EU oversight.

The experience below is organized by the inspection-critical systems most frequently challenged during FDA inspections and Notified Body reviews—design control, risk linkage, verification/validation adequacy, supplier control, and post-market signal response. 

Interpretive context for inspections:
My work focuses on the inspection-critical moments: design intent, risk ownership, verification adequacy, supplier control, and post-market signal response. The goal is simple—clear decisions, objective evidence, and traceability that holds up under FDA or Notified Body scrutiny. 

Education: 

B.S. Mechanical Engineering, University of Rochester

Additional Credentials:

ASQ approved Black Belt, GxP Compliance, Product Realization, and Design Control professional

Inspection focus: design intent, traceability, and verification rationale 

• New product development and systems integration lead for OrthoClinical Ortho Vision.

• Lead business process improvement to re-integrate project initiation and concept generation with the product development process and design control.

• Data driven approach to managing third party subsystem teams in Switzerland and ensured the proper functionality between software, fluids, and electro-mechanical systems.

• Lead systems project team investigations and provided a data driven structured approach to problem solving using my ASQ Black Belt skills. Lead CAPA (corrective action preventive action) investigations identified in the DTR (defect tracking record) system. Resolved DTRs triggered by field engineers' observations, customer complaints, and product design challenges.

• Lead systems integration investigations towards resolving field-initiated issues in a Class II extracorporeal-photopheresis (electro-mechanical) device using product design and development challenges.

• Subject matter expert for Design of experiment (DOE), Sample size determination and justification towards the support of technical files within the DHF structure.

• Lead new product development (NPD) verification activities of modified opto-mechanical subsystem within the automated clinical chemistry machine.

Inspection focus: CAPA effectiveness, DHF integrity, and regulatory decision-making 

• Provide technical quality leadership and support for class II electromechanical parenteral drug delivery device.

• Support combination product development efforts throughout clinical development, product registration, and commercialization. Work with internal and external partners, on efforts such as design inputs, quality planning, risk management, design verification and validation testing, design transfer, and design changes. Conversion from essential principles to general safety and performance regulations (gSPRs), MDD to EU MDR transition, FDA 21 CFR requirements and international standards (ISO, AAMI, ANSI).

• CAPA COACH working to resolve Class III Central Venous Catheter product and process issues (such as memorandum K97-1, the Regulatory decision process of when to submit a 510k for a change to an existing device).

• Performed design of experiments (DOE), Gage R&R, and statistical analysis in accordance with FDA guidelines 21 CFR 820, QSR ISO 13485, ISO 14971, MEDDEV 2.7.2 Rev4, and cGMP.

• DHF remediation ensuring compliance to 14971 and understanding the required changes in transitioning from MDD to EU MDR (Regulation EU 2017/745); utilizing post market hazard analysis in conjunction with clinical effects analysis as inputs into the risk management process;  HHA (health hazard analysis). 

• Lead for CAPA validations, generated and coordinated the execution of design change plans, Process Validation Plans, test method validations, Quality checks, and tooling qualifications.

• Lead validation activities for Biotech Pallsep including master validation plan (IQ, OQ, PQ) as well as test method validation planning and execution. Developed project schedule and responsible for updates.

• Lead facilities validation of purified water system and quality lab cleaning equipment (IQ, OQ, PQ). Developed project schedule and responsible for updates.

• Lead validation of annealing ovens across worldwide facilities, including training and execution (IQ, OQ, PQ)

• Developed and implemented bi-weekly statistical trend analysis report into the CAPA process to resolve FDA 483 warning letter concerns. 

• Lead and tracked DMR activities for biotech pallsep including DHF support.

• Trained engineers (Tijuana, California, Puerto Rico, England and New York) on DMAIC methods and trend analysis.

• Technical writing of all necessary documentation. 

Inspection focus: supplier control, system integration, and execution under oversight 

• Lead external partner (located in Switzerland) in all subsystem teams (barcode reading, blood sample handling, agglutination card assessment, incubator, centrifuge, and agglutination card transport between subsystems) of an automated immunohematology analyzer to get them back on schedule. Resulting in a timely product launch of the Ortho-Vision analyzer. 

• Lead Systems Integration and Product Development teams in the areas of Verification and validation of automated clinical chemistry and transfusion medicine systems - Class II Medical Devices. Team Leader for Therakos division system investigations. Developed test methods and verification plans. Risk based sample size determination for Verification and Validation execution. Generated documents in support of DHF.

• Lead commercial biotech Pallsep validation and overall DHF activities.

• Utilized Stage Gate and Six Sigma Black Belt champion principles to assess & communicate the manufacturing process control and capability of 193nm ARF high purity fused silica (HPFS) resulting in delivery ($1.3MM) of qualified prototype product to customers in U.S., Japan, and Germany.

• Managed creation, implementation and continuous monitoring of quality systems improvements.

• Technical manager abrasive water jet for Dynamic Lightweight Mirror (DLM) program.

• Managed facilities and abrasive water jet process capital improvements.

• Lead technology transfer of abrasive water jet pocket milling technology from vendor to Kodak.

• Managed ISO13485 & ISO14971 compliant verification & validation plan and execution activities in support of DHF.

• Improved the Low Temperature Fusion (ULE glass) Mirror assembly process reliability by 25% by designing new and modifying existing equipment for a ($4MM project).

• Increased equipment utilization from 25%-75% via Kaizen. Designed process fixtures and specified waste handling equipment for production ready capability ($1MM savings). 

• Implemented project management in an FDA regulated environment, KT analysis, TOPS, and Gemba to integrate FEA with PDMP process for improved metal and plastic injection molded product resulting in $50K- $300k savings.

• Participated in cross function teams including Marketing, Research and Development, Product Engineering, Prototyping, Design, and Quality and as a team we developed VOC surveys to assess the needs of the customer against future product designs. 

Schedule a Discovery call to confirm scope, identify the highest-risk decision points, and align on a defensible engagement plan.