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Manager, Software Validation

  • Anywhere

Company :
NuVasive

Location :
San Diego, California

Expiry Date :
Mon, 26 Apr 2021 23:59:59 GMT

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Description :
Manager, Software Validation US, US, CA – San Diego Minimum Level of Education Required: Bachelors Degree Percentage of Travel: Up to 10% Location: CA – San Diego Ref#: Job Summary and Primary Responsibilities As a Manager of Verification and Validation team, the specific duties/responsibilities include, but are not limited to: – Ensure the verification and validation plan and related protocols for medical device software and hardware system are defined, executed and reported in accordance with FDA QSR’s, ISO and specified Design Control Requirements to include 510(k) and international submissions. – Lead a team of 3-5 members. Including individual talent development and performance management. – Responsible for strategic planning and day-to-day oversight of the verification and validation team. * Identify staffing needs and determine individual project team member responsibilities – Provide management with plans and status updates on assigned responsibilities and goals and escalate issues in a timely fashion. – Verification and validation team representation for assigned product development teams, including associated risk management reviews. – Develop, implement and maintain test plans, protocols, test scripts and traceability matrix for design verification & validation. * Perform product / system risk assessments to ensure that functionality with a risk priority of high or critical are thoroughly tested. – Execute protocols/test scripts and document results. – Document and report issues discovered during verification and validation testing. – Management review and approval of system verification and validation related documentation and requirement specifications and any other product project related documentation. – Interaction with regulatory and partner auditors/inspectors as needed. – Maintain design verification and validation documentation in accordance with established departmental and corporate procedures. – Train individuals involved in verification and validation activities as needed. – Participate in review and update of Standard Operating Procedures (SOP) in the spirit of continuous improvement. – Identify and lead verification and validation team process improvements. – Possess excellent verbal and written communication skills. Required Skills / Capabilities – Good understanding of testing methodology and software development life cycle. – Adequate discipline and professionalism to work diligently within published FDA device regulatory guidelines and rigorously follow internal SOP, including documentation of the testing procedures. – Ability to handle multiple tasks while ensuring timely and accurate completion. – Strong management skills with demonstrated ability to effectively work across teams and functions. – Excellent organizational, interpersonal, verbal and written communication skills. Education and Experience – B.S. Degree in Computer Science, Engineering or related technical discipline – 7 or more years relevant work experience in medical device development and testing. – Experience and working knowledge of applicable regulations and standards: 21CFR 820, 21CFR Part 11, ISO 13485, ISO14971. – Experience with standards for medical device software development (e.g., IEC 62304 and ISO/TR 80002-2) preferred – Experience with oscilloscope, DVM and other electronic measurement devices preferred – Experience working in a continuous integration environment preferred – Familiar with Agile/Scrum development methodologies preferred – Experience testing embedded medical devices at system level (includes software and peripheral hardware components) preferred#LI-HM1 NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, or protected veteran status and will not be discriminated against on the basis of disability. The EEO is the Law poster options are available here. NuVasive’s EEO policy is available here. About NuVasive NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. The Company’s less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. The Company’s comprehensive procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. With more than $1 billion in net sales, NuVasive has approximately 2,700 employees and operates in more than 50 countries serving surgeons, hospitals, and patients. For more information, please visit .