Hardware Verification Engineer III

Fujifilm in Bothell, Washington, USA

Industry

Medical Devices

Opportunity Type

Full-Time

FUJIFILM Sonosite, Inc. -- If you are looking for work that matters, you’ll find it at FUJIFILM Sonosite.  As the creator of point of care ultrasound, we dedicate every day to the innovation and development of imaging solutions that enable clinicians to provide improved healthcare in leading institutions, underserved populations and communities in crisis around the globe.  At FUJIFILM Sonosite, we are in the relentless pursuit of answers that allow our customers to be confident that they are making the best clinical decisions for any patient, anywhere, anytime.  Members of the FUJIFILM Sonosite team embody our company values: Go boldly, Stay curious, Passion fuels us, Respect each other, Own it and Act with integrity. Headquartered in Bothell, WA USA, FUJIFILM Sonosite is the proud recipient of numerous prestigious design awards and has in excess of 145 patents.  Our point of care ultrasound systems are sold in more than 100 countries.

Summary:

The Hardware Verification Engineer III will lead hardware verification projects through product testing and participation on development teams. This position requires writing hardware test plans/reports, leading test resources, identifying issues, project scheduling and oversite of verification lab equipment and facilities. In addition the Hardware Verification Engineer III will develop, update, release, and execute formal test protocols to support hardware verification test efforts (i.e. humidity, temperature, shock, vibration, safety, EMC, etc.). Provide support for material compatibility testing of products with various cleaners and disinfectants. This Person will contribute to the continuous improvement of processes within the hardware verification group. Work with hardware development teams to improve product design, quality and reliability of point of care ultrasound equipment deployed in a wide range of environments.

Essential Job Functions:

• Manage hardware verification projects (write plans/reports, schedule projects for on/off site testing, manage test resources)

• Develop comprehensive product hardware/physical requirement specifications.

• Participate on development teams & quality engineering / value engineering teams.

• Utilize reliability tools (HALT, FMEA, etc.) to improve product quality.

• Develop/update, release, and execute hardware test protocols.

• Manage biocompatibility and material compatibility for use with various disinfectants.

• Mentor junior hardware verification test engineers/technicians.

• Responsible and accountable for carrying out the requirements of the company's quality system.

Knowledge and Experience:

• Requires 3-5 years relevant industry experience, preferably in an FDA or other regulated industry.

• BS in an engineering discipline (ME, EE, BIO E or similar).

• Knowledge of mechanical design and electronics.

• Knowledge and experience in electromagnetic interference/compatibility (EMI/EMC) testing and mitigation.

• Experience performing and overseeing hardware tests involving environmental lab equipment (thermal, humidity, vibration, etc.).

• Experience with bio- and material compatibility testing.

• Exposure to medical IEC 60601-1 or information technology IEC 62368-1 product safety compliance.

• Experience developing and executing test protocols, and composing test plans and reports.

• Experience with HALT, Reliability engineering principles.

Skills and Abilities:

• Excellent written and oral communication skills and the ability to work with a variety of people.

• Ability to work in a fast-paced, small team environment with minimal supervision.

• Flexibility in work hours required to meet test exposures and program completion dates

• Ability to assemble and operate electromechanical products.

• Moving and lifting of hardware is required.

• Ability to lift 25 pounds, with or without accommodations.

Salary and Benefits:

• $97,000 - $127,000 depending on experience + variable bonus opportunity

• 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

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