Terry Irwin Email & Phone Number

Mission Viejo, Ca, Us

Mission Viejo, Ca, Us

Irvine, Ca, Us

Irvine, Ca, Us

Nuvaira is developing a dual-cooled catheter-based system that delivers RF ablation to treat chronic lung disease in a novel therapy called Targeted Lung Denervation (TLD). Although TLD is currently under clinical investigation, our strategies include value-building elements aimed at speeding clinical trial approval such as ISO 13485 QMS certification and device CE Mark approval.Managed design control compliance for the Nuvaira TLD system and led design verification, risk management and usability analysis while assuring compliance to FDA QSR, ISO 13485, IEC 60601, ISO 14971 and ISO 62366. Established and maintained the QMS, served as a primary auditee for internal and third-party audits, and collaborated with Regulatory Affairs on Regulatory submissions and Technical File content. Related work activities:• Achieved MDD certification and acted as site quality lead• Mentor and coach staff while providing daily work direction.• Audit, maintain and improve the Quality Management System.• Lead Quality Management reviews and coordinate work related to key performance indicators.• Manage CAPA, complaints, and NCMR.• Audit critical suppliers and negotiate supplier quality contracts.• Direct sterilization validation and biocompatibility assessment of devices.• Assure OSHA compliance, provide training and evaluate risk to employees related to workplace safety and bloodborne pathogens.

Marlborough, Ma, Us

Operational and budget responsibility for design quality engineering, analytical quality assurance, metrology engineering, three test laboratories, and calibration across two sites. Led development of annual department goals and motivated staff to succeed.• Directed and coached an organization of sixty-four engineers and technicians.• Served as a site SME in third party and FDA site audits.• Led harmonization of laboratory operations with a sister site overseas.• Led implementation of a CFR 21 Part 11 compliant electronic records management system to reduce costs and manpower associated with routing, approval, management and storage of paper records while maintaining integrity of the DHF and DHR.• Directed integration of a world-class CFR 21 Part 11 compliant calibration management system (CMS) that closed compliance gaps, improved calibration records management and improved department service. Received a Quality Initiative Award for this effort.• Increased quality employee engagement and retention by developing a talent management process that was later used as a model by Human Resources for the site.• Heart of a Leader Award nominee.

Marlborough, Ma, Us

Provided quality assurance and engineering support to product development teams in the cardiology and peripheral vascular franchises. Investigated and resolved manufacturing issues. Worked closely with Regulatory personnel to develop 510(k) and PMA submissions, guided design specification development, and participated in design reviews while completing team deliverables for approval of class III medical devices.• Led FMEA analysis of new products and processes as a product development team risk management lead.• Defined statistical sampling plans, test methods and testing strategies.• Developed and qualified test methods for design verification, design validation, and post-production acceptance testing of angioplasty balloons, stents, catheters, and guidewires.• Completed gage repeatability and reproducibility (GR&R) studies using measurement systems analysis (MSA) techniques.• Authored design verification (DV) and design validation (DVal) protocols and reports.• Applied Installation Qualification (IQ), Operational Qualification (OQ), and Process Qualification (PQ) to qualify processes and equipment.• Designed and built laboratories and related electromechanical equipment.• Developed and supervised a design engineering team responsible for test development and qualification, analytical laboratory QA, and test equipment qualification, maintenance, and repair.• Provided independent review and guidance in the areas of design control, good documentation practices (GDP), and current good manufacturing practices (cGMP).• Defined manufactured product complaint action limits (CAL).

Coralville, Ia, Us

Directed and managed quality operations including complaints analysis and vigilance reporting. Implemented, maintained and improved the quality management system in compliance with ISO 13485 and FDA QSR 820. Led FDA, third-party, and internal site audits. Completed acquisition due diligence and ensured the successful integration of company quality systems.• Improved visibility and assured effective closure of issues by creating and implementing a CAPA and complaints database system that fed management review reports.• Created nonconforming material procedures and established a nonconforming material review board to disposition nonconformances and manage supplier corrective actions.• Defined first article requirements, control plans and process capability requirements for manufactured components and assemblies.• Reduced supplier nonconformances from 25% to 3% and internal nonconformances from 29% to less than 1% within 1 year by applying Pareto analysis and working with suppliers to resolve issues.• Built and qualified a class 10,000 cleanroom, and established procedures to manage and monitor environment cleanliness and bioburden controls.• Coordinated packaging validation and validation of EtO sterilization processes.• Monitored production batch sterilization efficacy and authorized release of sterilized batches.• Applied Six Sigma and Lean Manufacturing techniques while working cross-functionally to improve company processes.

Coralville, Ia, Us

Designed patented medical devices for image guided biopsy, urology, gynecology and brachytherapy procedures. Developed quality systems and processes aligned with worldwide regulatory requirements for class I and II medical devices.• Created manufacturing specifications and validated manufacturing processes.• Developed an ISO 13485 certified quality management system.• Reduced product development cycle times from 2 years to 6 months within 1 year by building a rapid prototyping lab and implementing computer aided design (CAD) and computer aided engineering (CAE) software into the design process.• Assembled technical files and product documentation for European CE compliance and FDA 510(k) submissions.• Coordinated toxicology and biocompatibility studies.• Led design verification (DV) and design validation (DVal).• Defined statistical sampling plans for incoming materials, components and assemblies.• Authored Installation Qualification (IQ), Operational Qualification (OQ), and Process Qualification (PQ) protocols and reports.• Supervised, coached and trained product development engineers.

Boston, Massachusetts, Us

Mba, Business

Bachelor Of Science, Mechanical Engineering