Manager, System Verification

Fujifilm

  • Bothell, WA
  • Permanent
  • Full-time
  • 10 days ago
Position OverviewThe Manager of System Verification is a key contributor in the product development progress, providing leadership, expertise, and coordination between teams, driving new and sustaining engineering product deliverables through the verification phase of the development process. The Manager System Verification leverages quantitative approaches for test design, system test approaches, drives automation of testing, and technology integration activities, to demonstrate visible and measurable progress for successful delivery as defined within our Product Development Process (PDP) and in compliance with FDA CFR's and ISO/IEC guidelines.The Manager of System Verification is responsible for a team of system verification engineers and offshore aides, who are responsible to ensure that FFSS products satisfy 21 CFR 820 and the needs of the FFSS quality system. His\her main role is to establish the team as a leading and guiding function in the engineering matrix with overall verification responsibility, meeting the businesses regulatory, compliance, and cost requirements. In parallel, the manager along with his\her team are essential in improving the cross-functional processes within the engineering organization, thus striving for high level of efficiency and effectiveness in execution.The leadership responsibilities include oversight of the system verification team in their day-to-day activities spanning the products entire lifecycle, talent, and people career development, driving functional excellence towards improving the effectiveness and expertise of the system verification team.Company OverviewAt FUJIFILM Sonosite, we reinvent how healthcare is delivered with point-of-care ultrasound technology. As the leader in bedside ultrasound systems, our innovations save lives—from premature babies in NICUs to trauma patients in emergency rooms.We’re looking for purpose-driven team members ready to build technology that impacts real-world scenarios, including natural disasters and even war zones. By joining FUJIFILM Sonosite, you’ll be part of a team that thrives on collaboration, out-of-the-box thinking, and a passion for life-saving innovations. Let’s make a difference together.Our headquarters in Bothell, Washington, blends riverside charm with urban amenities, quality schools, and an ever-evolving downtown—all part of the vibrant Seattle metro area.Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit:Job DescriptionEssential Job Functions:
  • Lead cross-functional project teams in the design and development of visual medicine through phase gate product development process from concept to launch.
  • Work with program management, systems engineering, system integration, clinical, and software engineering to define, evaluate, and derive test requirements, methods of new innovative product concepts to address unmet customer and business needs.
  • Work closely with the program manager and systems engineering to identify the changes to a product and arrive at a test strategy that encompasses all shipped hardware configurations and permutations.
  • Ensure that the system verification output meets the requirements of 21CFR820.30 and establish discoverable traceability.
  • Work closely with program management to effectively manage the scope and project deliverables.
  • Responsible for developing system verification plans.
  • Responsible for curating all objective evidence that our products meet design inputs.
  • Work with Quality and Regulatory Affairs to support regulatory activities specifically related to the introduction of new products (i.e., country registrations, submission, and follow-up of 510k), as well as responding to internal and external audits (i.e., FDA, ISO, other regulatory bodies).
  • Owns the system verification process, its execution, documentation, and compliance.
  • Support sustaining engineering initiatives for the strategic products manufactured in-house or at contract manufacturing sites.
  • Guide junior-level verification engineers in the context of process, project deliverables, and domain expertise.
  • Lead and participate in design reviews.
  • Provide technical leadership in various domains to ensure cross-functional alignment and success.
  • Support in requirements management process, helping streamline requirement changes and reusability.
  • Drive the automated test results integration into JAMA to streamline verification testing
  • Manage all aspects of the system verification team including, but not limited to hiring, performance management, succession planning, budget adherence and skill development of the team.
Knowledge/Experience:
  • Bachelor’s degree in electrical engineering, Mechanical, Software, or Biomedical. Advanced degree is preferred, or equivalent experience.
  • Minimum of 5-7 years of R&D experience with a proven track record of leading a team of Verification Engineers/Testers, ME and/or EE engineers in the development and commercialization of products within a regulated industry, preferably medical imaging.
  • Good understanding of 21CFR820 as it pertains to verification and validation of medica devices.
  • Experience with the following standards is preferred, but not required: ISO 14971, IEC 60601-1, IEC 60601-1-2, and/or IEC 62304.
  • Working knowledge of change control, traceability, and defect tracking.
  • Experience in leading or participating in requirement reviews and decomposition.
  • Demonstrated ability to: understand clinical scenarios, conceptualize technical solutions, explain concepts to implementation engineers, test and evaluate designs and prototypes.
Skills/Abilities:
  • Proven ability to communicate both verbally and written form to influence all levels of the organization, technical and non-technical.
  • Innate desire to learn the product architecture and applicable regulations.
  • Able to take initiative and quickly learn new concepts.
  • Able to lift 25lbs with or without accommodations.
  • Takes pride in their work with attention to detail and a desire for quality.
  • Strong interpersonal skills to work with other groups in an effective manner.
  • Strong analytical skills.
Salary and Benefits:
  • $125,000.00 - $1600,000.00/yr. depending on experience (Compensation will vary based on skills, experience and location; it is not typical to be hired at or above the top of the salary range).
  • Insurance:
  • Medical, Dental & Vision
  • Life & Company paid Disability
  • Retirement Plan (401k):
  • 4% automatic Company contribution
  • Fujifilm matches 50 cents for every dollar you contribute, up to 6% of your salary
  • Paid Time Off:
  • You can accrue up to three (3) weeks of PTO in your first year of employment
  • PTO increases based on years of service
  • Employee Choice Holidays:
  • Four (4) additional paid days off, based on date of hire in the calendar year
  • Paid Holidays:
  • Eight (8) paid holidays per year
FUJIFILM Sonosite offers a fantastic compensation package, including benefits, and a 401k program. Visit us today to learn more about our exciting technologies and how you can make a difference. To apply and obtain further details regarding key responsibilities and experience requirements, check out our careers page at .To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.#CB#LI-MWEEO InformationFujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.ADA InformationIf you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (ffss-hr@fujifilm.com or (425) 951-1200).

Fujifilm