Brian Hansen Email & Phone Number

Austin, Tx, Us

Lakeway , Tx, Us

• Responsible for all the company’s end-to-end testing requirements and execution, reporting directly to the CTO.• Lead, motivate, and engage a test team, providing technical expertise in maximizing overall equipment effectiveness and implementing continuous improvement solutions to achieve 100% on-time delivery for all NPI programs.• Create and maintain testing infrastructure, analyze product test yields, provide ATE expertise and overall performance for the lab.• Provide in-depth technical assistance and resolution when problems are encountered before, during, and after new product/equipment bring-up.• Collaborate with external developers to identify, define, and solve all developmental problems.• Collaborate with internal engineering to create engineering evaluation plans, development execution, and provide results feedback to refine plans and development.• Optimize overall equipment effectiveness, reduce maintenance cost, and establish predictive/preventive maintenance and calibrations for ATE test equipment.• Develop and establish equipment/maintenance training program.• Lead and drive projects on GLP/GMP for Lab operation which includes the FDA, IVDR, LEAN, Environment, Health and Safety (EHS) compliance, and ISO9001 process compliance.• Develops comprehensive and detailed team roadmap with staff involvement and ownership which supports meeting or exceeding business goals.• Develop high-performance technical staff by ensuring that each staff member has a timely and concise performance management plan which identifies specific accountabilities, training needs, and developmental plans.

Amsterdam, Noord-Holland, Nl

• Manages a cross-functional team responsible for the structured analysis of incidents and issues with products in the field for patient, user, or bystander clinical safety as well as applicable regulatory standards compliance and documents those findings for remediation.• Integral member of the Post-Market Risk Assessment Team ensuring proper decisions and actions are being taken for products in the field. Is designated to chair PMRA meetings when the PMRA Sr. Manager is absent.• Briefs leadership and multiple boards (i.e. Correction and Removal Review Board, Field Action Design Board, Change Control Board, etc.) on the results of product and accessory investigations, while assisting with final outcomes on all boards.• Has collaborated with multiple different disciplines, business units within Philips, vendors, and other key entities to fully and deeply assess product issues, risks, and hazards and assist with finding future solutions.• Ensures business commitment to product safety/compliance, and signs off declarations on product safety/compliance.• Leads all product safety/compliance related activities in the business to approbation ensuring that all regulatory requirements and Philips policies are handled according to corresponding product safety/compliance incident handling processes including review and decision making on product safety/compliance related escalations.• Ensures (support/consultation) proper reflection of all relevant regulatory requirements in all projects, including life-cycle management and verifies and validates designs regarding these requirements.• Makes and/or validates independent product safety risk assessments in line with conflict of interest rules as well as Philips & regulatory standards.• Made continuous improvements to the processes and documents which pertain to the managed program to ensure the highest quality, most efficient program.• Work closely with CAPA teams to ensure alignment between all documents.

• Hand-picked by the CTO/VP due to performance, knowledge of V&V methodologies (FDA CFR 21 Part 820 (g) and (f) and ISO 13485), as well as strategic agility and vision. Worked with minimal direction, guidance, anticipated future needs, issues, and was extraordinarily successful.• Led a team of 4 R&D V&V engineers, 3 engineering techs, and a lab manager while establishing functional, technical specifications, and documentation for the testing of hardware/software/systems/tooling, and validating integration of subsystems and systems.• Reviewed resumes, interviewed candidates to decide team integration, knowledge, and fit.• Participated in/led Device Failure Mode and Effects Analysis (DFMEA) to form risk-based decisions, and input reliability considerations.• Reviewed, evaluated, and derived requirements for testability; developed and executed comprehensive test plans, protocols, and reports while aligning to customer, company, and regulatory requirements; ensured timelines and cost constraints were met.• Was held to, and held my team to, high expectations, which required accountability in all capacities.• Represented V&V in all cross-functional teams, insisting on early V&V involvement to increase reliability and quality in design, as well as testability.• Wrote and edited protocols, performed statistical analysis of test results, and prepared comprehensive evaluation reports which verify and validate all parts of the system.• Performed integration regression testing to verify/validate incorporated fixes to software, components, subsystems, and systems. Documented findings, defects/problems.• Applied various validation and testing methodologies (e.g. Hall, Halt, Hass) while being highly knowledgeable of GMP, GDP, GLP, as well as IQ OQ PQ activities.• Able to develop validation approaches while defining and attempting to automate testing activities and applications where possible.• Served as Document Control Manager and Quality Engineer.

Santa Clara, Ca, Us

· Test integrated components in industrial tooling where all devices interface with Ethernet cabling, pneumatics, electrical controls, and surface fed liquids to complete semi-conductor cleaning and polishing.· Test and assemble complex components using engineering diagrams, schematics, and operational procedures to verify process controls.· Perform operational tests, fault isolation, and adjustments designed to analyze current procedures and tests to ensure design/manufacturing controls are correct and effective.· Due to my ability to learn and analyze new technologies quickly, was named the manager’s second in command after two months despite being the newest member of the 300mm team.

Washington, Dc, Us

· Managed complete systems from cradle to grave – used to be called life-cycle management, currently called Production Development Launch and Monitor (PDLM).· Managed contractors, hours, and certificates of completion and ensured all contractors/work were in compliance with contractual requirements.· Trained government employees, soldiers, and contractors in electrical theory, testing methodology, troubleshooting, and repair down to the circuit board level using blueprints, schematics, wiring diagrams, and maintenance manuals, reducing aircraft down-time by 16% in trained units.· Liaised between the government, engineering teams, item managers, customers, contractors, and vendors daily, expressing the needs and requirements of each to ensure all understood the intentions and requirements of the other stakeholders. · Reviewed/Approved proposed highly technical operational tests, troubleshooting, repair/rebuild, and/or calibration on electronic, pneumatic, and hydraulic systems. This increased system availability to 94% from 82% prior to my arrival.· Excelled in independent and team environments, functioned primarily independently.

Bethesda, Md, Us

· Represented Lockheed Engineering to provide on-site engineering solutions which resulted in increased system readiness from 87% to 98%. · Liaised between the military and Lockheed Martin Engineering headquarters to solve problems experienced by the military with highly complex LM systems, resulting in a reduction of repair times by 28% as well as a readiness rate increase of 11%.· Managed all Lockheed Martin testing, calibrations, equipment, scheduling, and budgeting at my locale.· Trained military personnel on proper maintenance procedures and use of engineering blueprints, schematics, diagrams, and maintenance manuals to fault isolate and properly build components and systems. This increased gunnery success rates to 97% and reduced gunnery exercise times by 38%.· Gathered, generated, and analyzed component metrics. This analysis reduced component failure rates by 42% as well as a 68% reduction in incorrect component replacement.· Received two Positive Significant Incident Reports as well as five Instant Recognition Awards for exceptional, efficient, and effective system fault isolation, and technical ability well beyond my peers.

Bethesda, Md, Us

• Responsible for fault isolation and repair of armament/electronic systems on 48 Apache aircraft using test equipment, multimeters, oscilloscopes, waveform generators, computer to aircraft interfaces, and blueprints which produced a system readiness rate over 90%.• Promoted to Lockheed Martin Field Engineering due to outstanding performance, and became the youngest LM Field Engineer ever.

Bachelor Of Science (Bs), Electrical Engineering

Bachelor Of Science (Bs), Business Administration And Management, General