Fujifilm Manufacturing USA, Inc

Clinical Validation Engineer

Fujifilm Manufacturing USA, Inc$95K — $115K *
Healthcare
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • RDCS and/or CCI (RCS) and/or RDMS certification required.
  • 4-6 years of experience in medical ultrasound imaging.
  • Preferred experience in the medical device and point-of-care ultrasound development.
  • Strong knowledge of ultrasound physics and instrumentation required.
  • Good Clinical Practice Certification required within 2 months of hire.

Responsibilities

  • Collaborate with product development teams to ensure systems meet clinical standards.
  • Conduct clinical testing including evaluations and validation.
  • Engage in research to maintain knowledge of ultrasound technology and clinical practices.
  • Advocate for user needs emphasizing reliability and ease of use.
  • Optimize product designs through continuous refinement and input.
  • Gather and analyze clinical needs from POCUS system users.
  • Participate in risk assessments and quality reviews.

Benefits

  • Medical, dental, and vision insurance.
  • Life and company-paid disability insurance.
  • 401k plan with company contributions.
  • Accrual of up to 120 hours of paid time off in the first year, increasing with service.
  • Additional employee choice holidays and paid holidays throughout the year.
Full Job Description
Position Overview

As a Clinical Validation Engineer, you will use your ultrasound expertise and skills to identify, document, design, develop, and test point-of-care ultrasound systems, imaging, and features. You will use your knowledge, curiosity, and industry best practices to ensure Fujifilm Sonosite products are clinically diagnostic, safe, and meet user needs as you actively participate in a range of research and development activities. You will conduct extensive research and gather key data points to define clinical workflows, guide requirement development and designs, and inform current and future product development.

Being a Clinical Engineer at Fujifilm Sonosite means that you are an instrumental part of a passionate cross-functional development team. We are dedicated to creating reliable, durable, and easy to use point-of-care ultrasound systems that provide meaningful solutions to our customers.

Job Description

Essential Job Functions:
  • Collaborate and provide clinical input to our product development teams throughout the R&D process to ensure systems are clinically diagnostic, safe, and meet user needs.
  • Actively participate in the planning, execution, data analysis, reporting, and presentation of clinical testing including engineering clinical evaluations, regression testing, and clinical validation.
  • Participate in a range of research and development activities to maintain and develop knowledge of technology, trends, clinical practices, and workflows related to POCUS.
  • Advocate for the customer's user needs throughout development with an emphasis on Reliability, Durability, Ease of Use, and Education.
  • Use your experience to refine and design state-of-the-art technologies in the field of point-of-care ultrasound.
  • Optimize systems to meet user needs and ensure ease of use in close collaboration with Ultrasound Engineering.
  • Research and capture clinical needs for users of POCUS systems.
  • Conduct and monitor research studies and protocols to help evaluate clinical features and workflows with end-users.
  • Provide clinical input to cross-functional teams to ensure requirements, testing, and reports are aligned with clinical workflows and user needs.
  • Participate as the clinical quorum member in risk assessments, service, and quality reviews.
  • Develop knowledge of product development processes.
  • Scan and review new features, systems, and transducers.

Knowledge and Experience:
  • RDCS and/or CCI (RCS) and/or RDMS
  • TEE experience preferred.
  • Minimum of 4-6 years of experience in medical ultrasound imaging.
  • Previous medical device industry experience preferred.
  • Previous point-of-care ultrasound development preferred.
  • Previous experience with POCUS clinical applications preferred.
  • Strong knowledge of ultrasound physics and instrumentation required.
  • Good Clinical Practice Certification required within 2 months of hire.
  • Strong desire to expand/grow their knowledge of ultrasound technology, workflows, and medical device development processes.

Skills/Abilities:
  • Excellent written and verbal communication skills.
  • Strong PC and system skills, specifically in MS Office and ultrasound applications.
  • Strong analytical skills and attention to detail.
  • Effective planning and time management skills with a history of accountability and meeting deadlines.
  • Ability to work independently as well as part of a cross-functional team in a fast-paced environment.
  • Ability to travel up to 20% of the time.
  • Hybrid role: In-office attendance required 60-100% of the time, as project schedules allow.
  • Ability to lift 25lbs with or without accommodations.

Salary and Benefits:
  • $95,000.00 - $115,000.00 depending on experience + variable bonus opportunity (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 120 hours of PTO in your first year of employment
    • PTO increases based on years of service
  • Employee Choice Holidays:
    • 32 hours additional paid time 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 www.Sonosite.com/about/careers.

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.

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About Fujifilm Manufacturing USA, Inc

Fujifilm Manufacturing USA, Inc is a subsidiary of Fujifilm Holdings Corporation, a Japanese multinational conglomerate that specializes in imaging and photography. Fujifilm Manufacturing USA, Inc is responsible for the manufacturing of photographic paper, film, and other imaging products in the United States. The company was established in 1988 and has its headquarters in Valhalla, New York. Fujifilm Manufacturing USA, Inc operates as a subsidiary of Fujifilm North America Corporation.
Learn more about Fujifilm Manufacturing USA, Inc
Size
72,332 employees
Industry
NASDAQ

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