Verification & Validation ManagerCompany: Digital Surgery Systems Inc.Job Posting Location: Goleta, California, United StatesFunctional Area: Research and DevelopmentWorking Model: OnsiteDays of Work: Wednesday, Tuesday, Thursday, Friday, MondayShift: 5X8Relocation Available: NoRequisition ID: 10614B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap and CAPS.Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.bbraunusa.comSUMMARYThis position will direct and oversee the teams, processes, and tools responsible for product verification and software validation testing, including software quality assurance. It is responsible for the creation and maintenance of test cases and protocols to ensure that product and software quality standards are achieved, and that all regulatory expectations are met. It will also oversee the execution and reporting of Verification test efforts, including document approval and release. This role will interface closely with software engineering, systems engineering, biomedical/clinical engineering, product management, project management, quality, and regulatory.ESSENTIAL DUTIES AND RESPONSIBILITIESinclude the following. Other duties may be assigned.Develop, lead, and manage the V&V engineering group.Define and track goal progress for individual team membersSupport the development and maintenance of Product and Software Requirements SpecificationsDevelop test cases, protocols, and plans; Perform and oversee execution of these test cases, protocols, and plans; Deliver final test reportsHardware and system testing against the product requirements, including testing against optical standards, visual perception and mechanical capabilityPreparation for and Management of External Testing, including: Safety testing per IEC-60601-1, Wireless, Shipping, EMC Testing, etc.Understand accelerated lifecycle testing to prove reliabilitySoftware verification testing against the software requirements specifications.Introduce V&V best practices in compliance with FDA and EU medical device product development, and measure team performance against best practicesDevelop test automation framework to achieve (1) early defect detection and (2) reduced manual test effort.Manage hardware and software resources required to support testingWork with project managers to ensure that projects are completed on time, and within budget.Contribute as needed to help the V&V team to achieve project goals and milestonesAct as the technical point-of-contact for customer reports issues and provide support to the Technical Support team as needed.COMPETENCIESTo perform the job successfully, an individual should demonstrate the following competencies:Ability to manage V&V team membersUnderstanding of medical device product regulations, FDA and EUAbility to maintain high team morale through excellent communication, management, and encouragement.Demonstrated ability to creatively and proactively solve problems.Flexible in working under changing and different work settings.Demonstrate knowledge of the company product development lifecycle and the process tools.QUALIFICATIONSEducation/ExperienceMandatoryRequires a minimum 8-10 years' experience in medical device development with a bachelor's degree or 5-7 years' experience in medical device development with a Master's Degree in science/engineering from an accredited university, or equivalent work experience in medical device development.Minimum of 2 years' experience supervising technical staff.Experience developing medical devices, or working in a regulated environmentUnderstanding of IEC-60601-1, IEC-14971, and IEC-62304 for medical device developmentExperience being in the operating room (OR) supporting live surgeries as a design engineer, tech. support, service engineer, or sales representative. Knowing OR sterility protocols, medical equipmentUnderstanding basic image processing concepts and techniquesHands‑on background in operation and use of standard test equipment; oscilloscopes, digital multimeters, frequency generators, calipers etc. Ability to troubleshoot and analyze electronics.Background in software test automationKnowledge of different medical imaging modes such as optical microscopy, intraoperative fluorescence, X‑rays, CT scans, MRI, OCT, etc.Experience working with Scrum/AgileLanguageDemonstrate excellent communication and documentation skills, both written and oral. Ability to read, analyze, and interpret technical procedures or governmental regulations. Ability to write reports and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.MathDemonstrate ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Apply concepts of basic algebra and geometry.ReasoningDemonstrate ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.Computer SkillsTo perform this job successfully, an individual should have strong computer skills, knowledge of Microsoft Word, Excel and Outlook. The individual should also be able to troubleshoot PC‑based systems, hardware, and software.PHYSICAL REQUIREMENTSThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this Job, the employee is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee must frequently lift and/or move up to 30 pounds and occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include color, distance and close vision.WORK ENVIRONMENTThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is frequently exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate.The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.BENEFITSB. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.Through its Sharing Expertise initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.EEO STATEMENTWe are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here .#J-18808-Ljbffr