Pear Therapeutics is the leader in prescription digital therapeutics (PDT) for serious diseases and tracking tools for clinicians and cost-effective solutions for payers. Pear has a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from the FDA.My Design Quality Assurance role works closely with software developers in an Agile framework to ensure the Software as a Medical Device (SaMD) follows regulatory requirements and software best practices. The role includes design control oversight. The role is responsible for and approves risk management, software test plans, and report documents. The role works with the clinical department on usability and requirements discovery and with the regulatory department for compliance issues. ◦ Advised product development team as SME in software design controls of internal procedures, and compliance with ISO 13485, FDA 21 CFR 820 (QSR), and IEC 62304. ◦ Drafted software development and risk management plans for design history files (DHF). ◦ Approved deliverables related to product testing, usability, and risk management. ◦ Collaborated with quality co-workers to improve risk management procedures and templates compliance to ISO 14971:2019. ◦ Active member of CAPA Review Board and a Complaint Review Board. ◦ Led CAPA investigation, coached action owners by drafting procedures, work instructions, and templates Approved final implementations.

A medical device manufacturer in Redwood City, CA provides a robotic surgical waterjet system to treat enlarged prostates in men. ◦ Developed statistics and wrote work procedure for complying with EU MDR Article 88 trend reporting resulting in notified body acceptance of the company’s first Periodic Safety Update Report. ◦ Approve test protocols and reports. Provide inspection and sampling plans. ◦ Wrote the sterilization validation reports for existing and new sterilization sites complying with ISO 11135. Managed ETO residual monitoring and new material testing per ISO 10993-7. ◦ Managed cleanroom and product microbial monitoring service providers. Released new sterile lot procedure resulting in faster sterile load processing and improved lot status tracking. Bioburden testing and statistical trending per ISO 11737. ◦ Wrote Validation Master Plans for two contract manufacturers in Costa Rico and China. ◦ Established SPC data gathering that predicts if cleanroom conditions drift out of specification and provided quarterly management review presentations resulting in no notified body audit findings.

A medical device manufacturer with 3800 employees, ~$3B in revenues providing arthroscopic surgery and sports medicine products. Managed quality activities through all stages of development for over 40+ products in arthroplasty, orthobiologics, veterinary, resectioning, and virtual image positioning while at the same time responding to complaints and audit findings. ◦ Collaborated with product design engineers, regulatory affairs, manufacturing quality, metrology, and procurement on critical design control deliverables resulting in successful new product development launches and speed to market. ◦ Applied Human Factor/Usability knowledge to new device design validation. ◦ Conducted risk assessment of pre-production devices (hardware and software) ◦ Remediated risk management for on-market devices, leading design failure modes and effects analysis, and approving usability tests. ◦ Remediated risk management files resulting in audited compliance to ISO 14971:2019. ◦ Wrote post-market data and competitor data reports to support risk management files. ◦ Developed training materials and presented classroom training on updated design control resulting in improved compliance and device development efficiency ◦ Collaborated with Engineering and Product Managers to develop and release quality control procedures for veterinary devices

An orthopedic medical device manufacturer that provides primary and revision implants for hip, knee, shoulder, and elbow joint reconstruction. The quality engineer assigned to product development teams. • Led and documented all safety-related complaint investigations and root causes analysis. Generated Health Hazard Evaluations for devices at risk of recall. • Compiled, reviewed, analyzed, and distributed metric reports for CAPA, and complaint investigations to identify trends and potential process improvements to senior leadership. • Performed internal audits of quality systems and supplier audits. Follow-up with stakeholders and suppliers to compose and then approve the issued action plans and perform effectiveness checks. • Implemented pre-approved rework loops that resulted in increased nonconformance processing speed from 5 to 2 days.

Zimmer Spine is 100% outsourced manufacturing. My responsibilities covered both product development and production. Involved supplier quality management for 23 suppliers and product development to assess risks, approve protocols and reports, compile DHF, and ensure compliance to design control procedures and regulations.An active member of the material review board. Process Validation: Participated in Validation Review Board for supplier process validation. Wrote and executed process validation for supplier and internal processes, leading to approved statistical methods and results.Risk Management: Generated quality plans, risk assessments, health hazard and human factor task analysis, and risk evaluations, resulting in improved project timelines and complete risk management files.Supplier Quality and Auditing: Conducted monthly presentations of product quality metrics, nonconformance trends, supplier audits, corrective actions, and equipment calibration status. Worked with audit suppliers in solving nonconformance issues. Developed supplier's process control plans and FMEAs. Approve supplier process validation, and initial capability assessment including first article protocol.GxP Training: Worked with legal to update the standard supplier quality agreement in response to an internal audit finding to meet regulatory requirements. Served as a member of the integration team to update supplier management procedures and forms. Served as SME on international standards (ISO, ASTM) and USA medical design control regulations and guidances.Management Manufacturing: Performed incoming inspections for complex measurements, resulting in a decrease in backlog.

An medical bio-medical device start-up company with plans to market its patented “dual-use” technology to combat Spatial Disorientation (vertigo) and Motion Sickness used by the military and aviation market in the US, Canada and EU. Served as the firm’s quality manager for submissions to regulatory authorities. Quality Management: Established the Quality Management System from scratch and obtained ISO 13485 certification for a new biomedical start-up company. Oversaw FDA 510(k) and European dossier submissions. Monitored clinical trials.Risk Management: Prepared and coordinated hazard analysis, patient risk assessment, process validation, device verification, testing. GxP Training: Trained executives and staff on FDA, European, and Canadian regulations.

Apollo is a pre-market start up firm that designs and develops endoscopic surgery devices for minimally invasive surgery.Served as the firm’s quality engineer responsible for assessing risks and compliance related to risk management, design control, complaint investigations, GxP training quality management, management supervision and process validation. Risk Management: Reduced aging nonconformances from 200 days to 60 days and an average 15 day turnaround. Determined FDA reportability of complaints.GxP Training: Conducted regulatory training programs on industry standards (21 CFR parts 11, 803, and 820). Established internal audit system. Trained staff to conduct 60 audits per year in key company processes.Wrote and reviewed procedures, validation protocols and audit reports.Quality Management: Ran material review boards and administered the CAPA and quality IT system. In addition, reviewed audit reports for issuance and oversight of the corrective and preventative actions.Process Validation: Created software validation protocols and executed IQ, OQ, PQ tasks, and released into production.Management Manufacturing: Supervised 5 quality staff for Class II medical device product realization, equipment calibration, preventative maintenance, document control, audits, and receiving, in-process and lot release inspections.

Abbott Diagnostics is a global leader in in vitro diagnostic systems and installs instruments worldwide for hospitals, labs, blood banks, physicians, and clinics with over 69,000 institutional customers in more than 100 countries. Firm’s quality engineer responsible for conducting audits and ensuring supplier compliance, specializing in photoelectric measurement suppliers for immunodiagnostic instrumentation, and supplier scorecards.Supplier Quality and Auditing: Ensured supplier complied with regulatory specifications and resolved supplier issues and inspection failures via CAPA projects and supplier enhancement plans which resulted in being selected as 1 of 3 SMEs being sent to the California site to implement FDA consent decree remediation activities. Conducted on-site audits, domestic and international for 17 suppliers.GxP Training: Trained suppliers on FDA GMP regulations.

An (medical device) manufacturer with clinical focus of cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. Firm’s quality engineer responsible for supporting new biomedical products introduction teams.Risk Management: Generated hazard analysis, patient risk assessments, process validation, device verification testing, and sterilization resulting in successful submissions to the FDA, PMA and 510(k) submissions and European dossier submissions. In addition, performed qualification testing of potential new products, accessories and components.GxP Training: Prepared training to Quality Control Engineers and Inspectors, and to Manufacturing Engineers for the transfer of the product into production.

An (supply chain and logistic) service firm responsible for serving the electronic and computer industries. Managed quality in the logistics fulfillment and Dell PC assembly processes for 250 persons. Conducted Pre-production Approval Process and First Article Inspection.Led internal and supplier audits.

Served as the firm’s technical lithography and photomask expert.Defined and specified the equipment, process recipes, and process flows for photomask quality control in a 200 person pilot line organization. Photomask is a master stencil for integrated circuits.Performed failure analysis for product designers. Applied accelerated life test failure analysis to photomasks. Isolated and replaced failing component increasing photomask lifetime by 660%.Designed experiments to support optical model development. Filed three patents and two technical publications.Established outsourced cleaning process with Compugraphics to contain undesirable photomask phase and transmission changes resulting in annual cost savings of $120,000.Designed test structure for monitoring optical proximity errors resulting in patent and used to qualify vendors.RIF in November 2003.

Implemented pilot plant capability into 24x7 manufacturing of binary and phase-shifting photomasks. Directed and organized complete module development, R&D technology implementation, ISO-9000/QS-9000 documentation, and operator training. Applied focused effort on yield, cycle time, and customer quality control. Managed team of 5 engineers, 5 technicians, and 2 data entry clerks with responsibility to implement pilot line capability into 24x7 manufacturing of advanced binary and phase-shift photomasks.Increased yield from initial 20% (Sept '00) 30 day cycle time to 40% and 15 day cycle time in four months by implementing real-time tracking and quality control methods in ISO9001 and QS9000 certified manufacturing. Led team that delivered ISO-9001 conforming phase-shift documentation in 3 months and passed QS9000 audit in sixth month. Zero Non-Conformance Reports generated. Process FMEA Received defect reduction award as part of team consisting of vendor, process, and equipment engineers.Designed and implemented a relational database to enable production tracking, reports, and exporting to engineering analysis software (JMP, WINSPC, Excel). Wrote database user manual with fundamental theory section used as permanent training document.Took first photomask dry etch operation from startup to manufacturing transfer in 6 months: 200% of goal.Wrote 11 technical application reports to transfer technology to other sites and technical report on after-develop defect inspection for the SPIE technical conference.RIF in March 2002

Participated in key technology roadmaps by completing process characterization & optimization for transfer into manufacturing of 0.35 & 0.25 CMOS, 256M DRAM, and 0.5 BiCMOS. Developed 0.15 & 0.12 etch processes with extension to 0.08 features. Applied working knowledge of statistical process control, process characterization, and control methods, defect reduction techniques, & design of experiments for process and yield improvements. Coordinated with process integration and product design groups to complete technology transfer. Formulated dry etch process for different substrates including metals (AlCu, W, TiN, Ti), classical dielectrics (nitride, BPSG, PSG, oxynitrides), low-k dielectrics (BCB, AF4, Teflon, Xerogel) and different masks including photoresists (I-line, DUV) and hardmasks (TEOS, HDP, SiON, nitride). Developed 0.15 & 0.12 plasma etch processes with extension to 0.08 features. Participated in key technology roadmaps by completing process characterization & optimization for transfer into manufacturing of 0.35 & 0.25 CMOS, 256M DRAM, and 0.5 BiCMOS.Designed analog and mixed signal circuits for plasma etch tool sensors as part of Manufacturing Methods, Science, and Technology (MMST) Dept. of Energy contract. Invented high-power RF power transducer for frequency based re-qualification of plasma processors. C and BASIC test stand programming for part reliability. Read and write AutoCAD schematics for both electrical and mechanical designs and component compliance.Developed programs for LTX and Genrad circuit testers as part of incoming inspection for TI missile manufacturing. Became lead test engineer responsible for program quality control.Wrote test software, built printed circuit boards (PCB), and wrote test procedures for integrated circuit (IC) test programs conforming to MIL-STD-883 sampling plans. Promoted to lead test engineer responsible for software program quality control in 6 months.