Medical Device Principal Quality Engineer

Medical Device Development Quality

Engineer

650-***-**** ************@*****.***

Professional Summary

Experienced Quality Engineer with 15+ years of expertise in development design and supply quality engineering across product R&D and manufacturing. Proven success in spearheading process improvements, implementing design controls, remediation and ensuring regulatory compliance with international standards such as PCBA Technology, SMT, IPC 610, IPC 620, IPC 2222, IPC 221, EMC, EMI, ESD, NC, NCR, CAPA, NCMR’s NDT, Leak Test Remediation, Risk Management ISO 14971, EU MDR, TGA, FDA QSRs, ISO 9001, IEC 60601, and ISO 13485. Excel in driving cross-functional collaboration to enhance processes and procedures.

Work Experience

Canary Medical March 2025 - Currently

Carlsbad, CA

Sr. NPI Electrical Design Quality Engineer

Product Line: Smart Implantable Medical Devices

Support Research & Development (R&D) teams during the design phase, leading risk management activities, conducting design reviews, and ensuring designs meet safety and regulatory requirements. Participated in design reviews, ensured design inputs met requirements.

Monitor Canary supplier performance, led qualification activities, and drove supplier development for electrical circuit board & components.

Assure Quality System are in full compliance, ISO14971, IEC 60601, 60601, IEC 60730 and international quality.

Lead PCBA process improvement, Validation Plan

Corrective actions related to audit findings, nonconformance product

Support PCBA Front End and Back End Supplier Process Plan

Support, Review and Manufacturing MIP’s, Process Plan, Incoming Inspection Method, Compliance Investigation, Risk Management (DFMEA),

Author Internal PCBA process guide

Review of the SWQA work team and liaison between development and quality department. Design Verification/ Validation test protocol review.

Review Design History, Design Trace Matrix for accuracy, clarity and consistency

Author Electrostatic Supplier Audit Check list

COOK MEDICAL, Indiana (12/ 2023 – Apr 2024)

Sr. Design Quality Engineer

Product Line: Balloon Catheter and Wire Guide (Class I & II Medical Devices)

Reviewed and investigated customers’ complaints, performed root cause analysis. Revised and recommended a new process control for ongoing compliance, risk management and quality improvements.

Identify failure caused by performing root cause analysis defect concentration diagram analysis.

Generated list of areas requiring improvement that led to reducing defects associated with cost.

Identified common issues, potential areas requiring improvement, and opportunities to enhance product quality.

Worked on the risk management documents per FDA regulations, EU MDR guidelines and PMDA.

Merck Medical Inc.

Sterile Diluent Prefill Syringe (PFS)

MDCP Senior Product Quality Scientist III 07/2021 – 12/2023

●MDCP Quality support for cross-functional teams, overseeing product development and compliance support for Merck Pre-Fill Syringe (PFS) Combination Products

●Developed technical solutions to safeguard PFS compliance with FDA 21CFR 820's and 21CFR 4 for Combination Product, ISO 14971 Device Risk Management, and other applicable regulations.

●Working knowledge reviewing and approving Technical File to meet MDR compliances

●Reviewed and approved design control and device risk management documentation for regulatory filings, clinical supply, development, design transfer qualification, and post-marketing surveillance

●Enacted process improvements to streamline product development lifecycle, reducing time to market.

●Supported all stages of combo product development, including New Product Introduction (NPI) and supplier quality, by working closely with external partners.

●Assessed and approved verification/validation test protocols and reports to ensure test methods met regulatory requirements and quality objectives.

Summary

Collaborated with the Combination Products Group for the development of devices (PFS, Diluent) provide knowledge of the characteristics of the drug product and providing expertise to any collaborative study design for products delivered via devices.

Contributed to relevant Drug Product sections in regulatory submission and response to address regulatory questions.

Contributed to resource planning, objective setting, and any other business-related processes as appropriate. reviewed and approved device combination product documentation in support of regulatory filings and audits of data, policies, procedures, and systems to ensure compliance with Medical Device and Combination Product current Good Manufacturing ruling (21CFR part 4), Device Risk. Reviewed and approved verification/validation test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives. Provided guidance to Manufacturing Division, Research & Development Division device functions and other personnel to ensure end-to-end Design Control principles are implemented effectively.

Johnson & Johnson

Catheter

Complaint Remediation Quality Engineer – 10/2021 – 03/2022

●Rendered support to R&D and Post Market Surveillance teams throughout design life cycle and product transfer into manufacturing, ensuring compliance with quality system regulations.

●Led system and hardware quality during design input process, design verification & validation (V&V) activities, and product realization, contributing to complaint closure, FI analysis, and quality reviews.

●Instituted appropriate quality and design plans covering all product life cycle stages, conducted product failure analysis, and reviewed complaint documentation.

●Prepared information for quality management and operational reviews, including trend charts and Pareto analysis.

●Evaluated device failure modes, manufacturing documentation, labeling, and instructions for use, resulting in 4% decrease in product defects.

Integra Life Science Hybrid

Soft Tissue Reconstruction

Reliability & Risk Management Consultant 10/2019 – 02/2021

●Reviewed and remediated Integra Bovine legacy product design history files, conducting gap analysis, identifying and resolving critical issues before production.

●Compiled and analyzed data, authored, reviewed, and approved protocols and reports, making recommendations for changes or improvements while ensuring traceability.

●Collaborated with Subject Matter Experts (SMEs) and internal/external reviewers to identify gaps and mitigate risks, implementing corrective actions that decreased failure rates.

●Reviewed complaint data of legacy products dating back 5 years, collecting and analyzing data to verify legacy product performance, operation, and safety.

●Established design and development processes in compliance with 21 CFR 820.30, ISO 14971, EU/MDR, and ISO 13485 requirements.

●Support New Product Development (NPD), Sustaining Engineering and Continuous Improvement projects of varying Product and complexity in compliance to ISO 14971 (2019) and IEC 62366 (2015).

Summary:

Supported manufacture location, product, and process remediation of Integra Bovine legacy Product Design History Record (DHR).

Performed gap analysis to discover findings, and remediating as necessary, files include risk management and product requirements, design controls, design inputs, design outputs, design verification, design validation, DFMEA Device Master Record, Design History File Checklist.

Lead Product Transfer Remediation Design and Development Plan (DDP), Design History File (DHF), Device Master Record (DHR) gap Analysis, Prepared Design Review presentation slide.

Support Design Verification, Design Validation and Design Trace Matrix for product and process transfer Remediation in accordance with internal quality system procedures.

Compiled and analyzed data, reviewed, approved protocols, reports and make recommendations for changes or improvements and maintains traceability.

Ensure transfer process remediated documents are in audit ready in accordance with Integra Quality Remediation Plan in alignment with external agencies.

Worked with the regulatory and external Reviewers to identify gaps and mitigate the risks.

Ensure the same level of product quality or better is attained as original facility by confirming that the manufacturing process can be reliably replicated at the new facility. Applied process verification and validation test method making sure transfer processes scalability can be produced at larger quantities maintaining effectiveness and quality in accordance CFR 820.70, 820.75, ISO 14971 and ISO 13485.

Pfizer Meridian Medical Technologies

Autoinjectors

Design Control & Risk Management Quality Manager 07/2018 – 10/2020

●Led quality engineers and technicians through the design control process, implementing comprehensive training programs resulting in improved performance and efficiency within the R&D team.

●Managed resource allocation for Auto Injector Development projects, safeguarding optimal utilization of resources and timely completion of deliverables.

●Mitigated complex problems during product development, identifying root causes and instituting preventive measures to ensure continuous improvement and prevent re-occurrence.

●Guided design assurance engineers in orchestrating design control and risk management processes, guaranteeing compliance with applicable standards and regulations throughout the product lifecycle.

●Preserved adherence to FDA regulations and company policies throughout the development process, minimizing compliance risks.

Summary:

Support Auto Injector Process Transfer Remediation Design and Development Plan (DDP), Design History File (DHF), Device Master Record (DHR) gap Analysis, Device Master Record (DMR), Design Trace Matrix (DTM), Manufacturing Process Qualification Procedures, Manufacturing Process Qualification, Manufacturing Process Control.

Support Design Verification, Design Validation and Design Trace Matrix for product and process transfer Remediation in accordance with internal quality system procedures.

Ensure transfer products / process adhere to the internal quality system and guidelines established by regulatory bodies by validation studies, monitoring all processes and outcomes, and routinely evaluating and updating validation methods. Lead and implemented process control SOP, by creating control flow chart connecting process input / outputs and ensure repeatability.

Complied and analyzed data, wrote, reviewed, approved protocols, reports and made recommendations for changes or improvements and maintains traceability.

Ensure transfer process remediated documents are in audit ready in accordance with Meridian Pfizer Quality Remediation Plan in alignment with external agencies.

Worked with the regulatory and internal and external Reviewers to identify gaps and mitigate the risks.

Ensure the same level of product quality or better is attained as original facility by confirming that the manufacturing process can be reliably replicated at the new facility. Applied process verification and validation test method making sure transfer processes scalability can be produced at larger quantities maintaining effectiveness and quality in accordance CFR 820.70, 820.75, ISO 14971.

Electrolux Anderson SC

Sr. Global Electrical Design Quality Engineer 10/2013 – 12/2018

●Lead / Mentored North America personnel on ESD awareness, ensuring widespread knowledge and consistent implementation of ESD protocols across the organization.

●Collaborated with suppliers to identify opportunities for process and product improvement, enacting effective strategies to enhance quality and efficiency.

●Safeguarded full compliance of Quality Systems with ISO-9001, EN60335, IEC60730, and other international quality standards, conducting regular audits and instituting corrective actions as needed.

Dexcom Inc.

Sr. R&D Electrical Quality Engineer – 11/2008 – 2/2013

Lead Supplier Quality Engineering effort for manufacturing sites in Juarez (Mexico), Shenzen (China), and Ireland.

Lead Process Development and Product Qualification of supplier product for New Product Introductions, including product acceptance strategies

Manage and resolve supplier quality performance issues in conjunction with site functions.

Support or lead continuous improvement initiatives driving supplier risk reduction.

SUPERVISORY

Serves as manager of the Quality Assurance department.

Directly supervises Quality Engineering activities.

Interviews, hires, and trains employees.

Plans, assigns, and directs work; appraises performance, provides employees with performance feedback; addresses complaints and resolves problems.

Assess the skills and capabilities of the quality engineering staff.

Ensures staffing and work assignments are effectively managed to support execution of the business plan.

Additional Experience

Covidien (MAYA) Sr. Principal Hardware Quality Engineer; Masimo Inc. Senior R&D Design Quality Engineer; Dexcom Inc. Senior R&D Electrical Quality Engineer

Skills

Medical Device Quality Engineering, Regulatory Compliance, Product Remediation, Research & Development (R&D), Root Cause Analysis, Nonconformance (NC), EU MDR Tech. Files, Software Integration, Software Regression Test, Process & Quality Improvement, Metrics Reporting, Product Development, SaMD, Team Leadership.

Education

Master of Science in Electrical Engineering San Francisco Bay University

Bachelor of Science in Electrical Engineering Cogswell Polytechnic

Certifications

PCBA IPC Trainer Advance IPC Electrical Designer DFSS Lean Manufacturing Training Kaizen Method Certified ASQ Quality Manager Training

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