Dawn Strahler, CQE, EIT
dawn [dot] strahler [at] alumni [dot] hmc [dot] edu
Quality and engineering professional with over fifteen years of experience in the medical device and biotechnology industries. Expertise in project and process execution of device development and quality systems. Strengths include knowledge of quality and business practices, development of comprehensive systemic solutions, application of engineering principles to quality issues, and cross-functional interaction with technical teams.
Obtain a technical leadership role in a small to medium sized medical device company in the San Francisco bay area. Be a key representative in innovative new design projects. Utilize my skills as a systems oriented quality engineer to improve efficiency and usability of development processes.
Intuitive Surgical Inc., Sunnyvale, CA 2013– present
Sr. Quality Engineer Level IV Aug 2015 -- present
Sr. Quality Engineer Feb 2013 -- Aug 2015
- Device Launch- Support US and OUS launches of 30+ da Vinci® Xi reusable and disposable accessories, including cannulas, obturators, seals, drapes, cords, and others.
- Design Control- Represent quality engineering on product development team for accessories of robotic-assisted minimally invasive surgery systems, with input into risk management, requirements definition, design verification and validation test plans and execution, design reviews, and regulatory filings.
- Product Introduction- Support new product introduction projects through execution of process controls, equipment qualification, process validation, and manufacturing transfer.
- Final Quality Inspection- Develop quality test procedures for in-house manufactured and CM finished goods to ensure compliance with user needs, risk mitigation, and design specifications.
- Quality Advocacy- Identify opportunities to improve product quality via cross-functional process and management changes, and implement procedural updates.
- Project Management- Provide guidance and mentoring for design for quality practices, protocol development, and regulatory requirements.
Acclarent, Inc. (Johnson & Johnson), Menlo Park, CA 2010 – 2013
Sr. Engineer, Product Development Quality May 2010 -- Feb 2013
- Device Development- Represent quality engineering on cross-functional development teams for patient contact devices, including a balloon sinuplasty device, sinus irrigation catheter, and device-drug combination product.
- Design Control- Develop quality deliverable strategy for product development stages from project planning and definition to manufacturing transfer.
- Risk Management- Integral contributor to risk management activities for top down hazard evaluation, bottom up design failure analysis, and process failure assessment. Review and update risk management files for ongoing post-market surveillance.
- Biological Safety- Manage biocompatibility and chemical characterization evaluation plans for limited and prolonged duration breached mucosal membrane contact devices.
- Transit and Aging- Coordinate packaging validations and shipping validations of devices for domestic and international transport in unit cartons and shipper containers. Perform shelf life studies using accelerated and real time aging techniques.
- Sterilization- Complete ethylene oxide (EO) sterilization product adoptions.
- Regulatory- Review FDA documentation to support IDEs, 510(k) clearances, and CE marks.
- Test Method Validation- Conduct TMV for design verification and lot acceptance testing methods.
- Operations- Support ongoing product manufacturing, resolving non-conformances in receiving inspection and production, CAPA investigation and closure.
- Supplier Quality- Communicate with suppliers regarding deviations and feedback for contract testing projects. Provide input on sampling plans for component supplier controls.
- Systems- Generate and implement improvements to quality system documentation and company processes such as biocompatibility, receiving inspection, in-process monitoring, shelf-life. Ongoing projects include electronic design history file, phthalate policy, engineering build documentation.
- Community- Participate in Safety Committee.
Stellartech Research Corp., Sunnyvale, CA 2003 - 2010
Sr. Quality Systems Engineer Jan 2009 - May 2010
Sr. Quality Engineer Dec 2006 - Jan 2009
Quality Engineer Jun 2005 - Dec 2006
Mechanical R&D Engineer Aug 2003 - Jun 2005
- Quality Systems- Analyze and improve system documentation including engineering change orders, training, procedure and component specification formatting, manufacturing authorization, rework, and nonconforming material reports, service and complaint handling, customer quality agreements.
- Medical Devices- Quality collaborator for multi-year projects for patient contact devices, energy generator systems, and accessories for soft tissue coagulation for a variety of indications, with mucosal membrane and indirect blood path contact.
- Design Control- Review and maintain Design History File documentation. Perform ongoing quality engineering activities to improve device designs and manufacturing processes.
- Risk Management- Perform risk management analysis. Coordinate and perform field complaint investigations and Corrective and Preventative Actions (CAPA).
- Regulatory- Assist with regulatory submission documentation.
- Verification and Validation- Design, review, and perform design and process validations and verifications such as bond strength, cleaning, electrical integrity, and data programming. Design and implement test and assembly fixtures and procedures for use in verification and manufacturing.
- Documentation- Create, review and approve Device Master Records for product produced in a controlled environment area (CEA), from component receipt and kitting, through lot manufacturing, packaging, sterilization, and product release.
- Packaging- Complete development activities for product marketing including packaging and labeling, and perform shelf life studies and packaging validations.
- Device Release- Review and approve Device History Records for finished device release.
- Sterilization and Biocompatibility- Manage biocompatibility testing, and ethylene oxide (EO) sterilization validations, including mixed and minimum/maximum loads.
- Design- Design and develop balloon catheter sub-systems.
- Leadership- Perform training of employees, and supervise technicians.
- Community- Coordinate Emergency Response Team and company activities committee.
Hyseq Pharmaceuticals, Inc., Sunnyvale, CA 1998 - 2002
Biopharmaceutical Engineer/ Process Engineer 3 Oct 2001 - Jul 2002
Robotics Integrator Aug 2000 - Oct 2001
Jr. Robotics Integrator Oct 1998 - Aug 2000
- Automation- Developed and implemented high precision large gantry robotics systems for use in laboratory automation of genomic research (clone replication, PCR inoculation, DNA spotting, hybridization, and clone retrieval.)
- Programming- Programmed robotic equipment in Java to perform duties and interface with SQL databases.
- User Needs- Interfaced with scientist users throughout the design process to ensure all requirements met. Integrated new devices into production line and configured system to meet customer needs.
- Maintenance- Maintained production systems for maximum functionality and minimal down-time. Prevent and detect future problems. Upgraded systems.
- Documentation- Wrote documentation and Standard Operating Procedures (SOPs).
- Prototyping- Machined and assembled prototypes for upgrades and new robotic tooling.
- Computer Management- Implemented Computerized Maintenance Management Software.
Certifications and Education:
ASQ Certified Quality Engineer 50283, Dec 2006
Engineer-In-Training XE106099, Jul 1998
Bachelor of Science in Engineering, Harvey Mudd College, Claremont, CA, May 1998
Society of Women Engineers (SWE), Lifetime Member
American Society for Quality (ASQ), Member
Regulatory Affairs Professionals Society (RAPS), Member
Association for the Advancement of Medical Instrumentation (AAMI), Member
Temporary and Part Time Experience:
Planet Granite, Santa Clara and Sunnyvale, CA
Instructor/Supervisor, Nov 2002 to Dec 2010
Taught beginning and technique lessons, scheduled and managed staff tasks, registered customers, coordinated and facilitated events and sales.
Debbie Lyn's Costumes, Sunnyvale, CA
Seasonal Associate, Halloween 2002
Helped customers find costumes, get ideas.
Du-All Safety and Precision, Fremont, CA
Temporary Administrative Assistant, 1998
Performed reception duties, updated website, assisted with class preparations.
Silicon Light Machines, Sunnyvale, CA
Contract Consultant, 1998
Created Visual Basic Graphical User Interfaces (GUIs) and Visual C++ software.
University of California Santa Barbara, BioMaterials Engineering
Summer Research Assistant, 1996 and 1997
Conducted research related to morphological changes in sustained release drug delivery system using Transmission Electron Microscope (TEM). Researched formulations of hydrogels. Constructed lyophilization apparatus.
Lasers By Fifi, Claremont, CA
Business Manager, 1995 to 1997
Maintained all records and budget for small business using computer system. Scheduled and planned operations.
Curriculum Engineering Projects:
Irvine Ranch Water District,Irvine, CA
Team Leader, 1997 to 1998
Managed five person team developing and implementing customer oriented Internet presence via series of consistently designed web pages.
IsoStent Inc., San Carlos, CA
Spring Team Member. 1997
Designed heating and fluid flow system in accelerated fatigue test system for coronary artery stents with team of four.
Dunlap Elementary School, Yucaipa, CA
Team Member, 1995
Designed and specified playground to meet current safety regulations with team of five. Constructed parts of final design prototype. Prepared sections of final report.