Safeguarding quality and compliance across the medical device lifecycle — from concept to commercialization.
I take medical devices from concept to commercialization — building the quality systems that ensure products reach the end user safe, effective, and compliant.
With almost eight years across R&D and Quality, and dual master’s degrees in Industrial and Mechanical Engineering, I work at the intersection of engineering innovation and regulatory rigor. My practice spans early-stage design inputs and feasibility through design controls, risk management, UFMEA / DFMEA / PFMEA, design verification and validation, process and test method validation, supplier quality, sustaining engineering, and post-market surveillance.
The work I value most is making complex quality systems better — through rigorous standards application, data-driven decision-making, mentorship, and the kind of cross-functional problem-solving that bridges R&D, regulatory, manufacturing, and operations.
Almost 8 years across R&D and Quality
Class I, II, and III medical devices
M.S. Industrial Engineering
M.S. Mechanical Engineering
ISO 13485 · ISO 14971 · FDA QSR/QMSR
EU MDR · IEC 62304 · 21 CFR Part 11
Eden Prairie, Minnesota
Minneapolis / St. Paul Metro
I cover the full medical device lifecycle — from translating user needs into design inputs through commercialization, sustaining support, and post-market feedback. The practice is grounded in risk management, traceability, audit readiness, and execution-ready documentation.
Design and development plans, user needs, design inputs, design outputs, design reviews, traceability matrices, and DHF structures built to withstand FDA and notified body scrutiny.
Risk management plans, hazard analyses, risk evaluations, residual risk and benefit-risk reasoning, plus cross-linking to verification, validation, and post-production information.
Cross-functional facilitation of use, design, and process FMEAs with robust severity/probability alignment, mitigation ownership, and clear feed into control strategies and V&V planning.
Protocol authoring, traceability from requirement to evidence, statistical rationale, usability validation alignment, and execution support for bench, functional, and system-level testing.
Validation strategies and execution-ready protocols for equipment, utilities, and manufacturing processes with defined acceptance criteria, challenge conditions, and GDP discipline.
Analytical and visual method validation, measurement system studies, repeatability and reproducibility assessment, and statistical confidence that the method can truly detect product variation.
Sterilization validation support, reprocessing considerations, packaging integrity inputs, and aging strategies that link shelf-life claims to defensible evidence rather than assumptions.
Complaint trending, health hazard evaluation input, structured investigation methods, CAPA development, effectiveness checks, and feedback loops into risk management and design controls.
Supplier qualification, PPAP/APQP understanding, quality plans, control strategy alignment, incoming quality requirements, and site-to-site manufacturing transfer risk management.
Gap assessments, SOP and record review, mock-audit readiness, traceability health checks, and remediation support for FDA, ISO 13485, EU MDR, and internal quality system audits.
SaMD and software-enabled device quality support including software requirements traceability, SOUP review, configuration management, cybersecurity considerations, IEC 62304, ISO 14971, and 21 CFR Part 11 alignment.
Sustaining support through production monitoring, complaint and nonconformance trending, CAPA effectiveness, process capability review, yield and scrap analysis, SPC/control-chart interpretation, line-clearance and DHR review, and change-impact assessment.
Worst-case product selection, residue limit rationale, swab and rinse recovery studies, acceptance criteria development, cleaning validation protocols, and lifecycle revalidation after process or equipment changes.
Submission-ready documentation support for 510(k) and eSTAR packages, predicate comparison inputs, risk documentation cross-references, software and cybersecurity documentation coordination, and Q-Sub / deficiency-response discussion support.
My work centers on the disciplined application of ISO 14971:2019, ISO 13485:2016, and 21 CFR Part 820 / QMSR expectations across the device lifecycle. I favor design controls that read as a coherent quality argument from user need through post-market learning.
All engagements are anonymized. Product identifiers, client identities, and proprietary methods are abstracted to protect confidentiality. The examples below describe the class of problem and quality approach, not a named client project.
Work has included structuring user needs, design inputs, design outputs, reviews, and traceability matrices so that requirements, risk controls, verification, validation, and design transfer records read as one consistent system rather than disconnected documents.
When programs span intermediates, accessories, sub-assemblies, and finished devices, the risk file must reconcile scope boundaries while preserving a consistent hazard universe. The output is a risk structure that withstands challenge on traceability, residual risk, and benefit-risk logic.
Effective FMEA work is not passive documentation. Engagements have included driving cross-functional severity calibration, aligning failure modes to practical controls, and surfacing high-risk issues early enough to shape design architecture, process flow, and control plans.
Validation packages commonly fail because of scope bleed, weak traceability, poor naming discipline, or missing acceptance rationale. The approach here emphasizes execution-readiness before approval, strong requirement-to-test linkage, and GDP discipline during execution.
For software-enabled devices, the work includes connecting software requirements, architecture, verification evidence, configuration management, unresolved anomalies, and cybersecurity considerations back into the broader design control and risk management system.
Submission support has involved ensuring that risk management, V&V evidence, labeling, software documentation, and design history materials are submission-ready and internally coherent for 510(k), eSTAR, technical file, or pre-submission discussions.
The website is intentionally selective. For complete experience details across Evergen, Johnson & Johnson MedTech, Smith & Nephew, TE Connectivity, Phillips-Medisize, and earlier roles, use the resume links below.
This site is intentionally curated around the strongest quality themes: design controls, risk management, validation, sustaining quality, and regulatory readiness.
Use the actions below to open the PDF, download it, or schedule a discussion. This keeps the site elegant while still giving recruiters and hiring managers the complete detail when they want it.
I’m interested in connecting with engineers, regulatory professionals, recruiters, and medical device leaders who care about building safe, effective, and compliant products. If you'd like to talk about quality leadership, design controls, risk management, validation, or a potential opportunity, please reach out.