FUJIFILM Holdings America Corporation · 1 month ago
Reliability Engineer (Medical Device Industry)
US-WA-Bothell
Full-time
Onsite
Mid, Senior Level
$104K/yr - $115K/yr
5+ years expFUJIFILM Holdings America Corporation is a leader in bedside ultrasound systems, and they are seeking a Reliability Engineer to support R&D Systems Engineering in developing Point-of-Care ultrasound medical devices. The role involves supporting the entire lifecycle of ultrasound systems, leading reliability testing programs, and collaborating within a cross-functional team to ensure product reliability and integrity.
Artificial Intelligence (AI)Machine LearningMotion CapturePhotographyPrinting
Responsibilities
Work hand in hand with the Program Management, Product Management, and discipline leads to ensure the overall product/solution system integrity from concept to end of life of the product, including meeting all expectations from major stakeholders like Systems Engineering, Manufacturing, Quality, regulatory bodies, and Servicing, in addition to customers and patients
Support competitive benchmarking analyses to drive ongoing product improvements and enhancements
Collaborate with Product Management to develop reliability goals for future products
Allocate reliability goals to lower levels (subsystem, components)
Develop appropriate test plans and determine preliminary reliability assessments and estimates
Lead and conduct reliability testing programs to mitigate high-risk areas of the design and demonstrate product reliability prior to product launch, including accelerated life testing
Participate in risk management activities, FMEA, and safety risk assessments to mitigate risks and design for reliability
Work within a cross-functional team to weigh cost factors, resolve technical conflicts, and align on paths forward
Create, review, and release reliability documentation, including analysis reports, test reports, and summary reports
Teach Design for Reliability strategies and methods to engineering teams who will help implement them
Gather and encourage lessons learned from NPI projects and marketed product performance
Engage with User Interface, Hardware Engineering, Product Management, Clinical Engineering, Manufacturing, Operations, and V&V teams to ensure stakeholders’ needs are addressed in the reliability program
Keep abreast of new developments in relevant technological domains
Advise on change requests for system and related products
Qualification
Required
BS in relevant engineering, statistics, or data analysis field
Minimum 5+ years' experience in a medical or other regulated industry (medical desired), with experience leading or supporting Design for Reliability efforts for product development
Expertise in reliability software tools, such as Reliasoft, Weibull++, Minitab
In-depth understanding of both hardware and software for integrated products, including a strong understanding of reliability assessments and Design for Reliability programs for PCBA designs
Strong understanding of safety risk management, including FMEA, fault tree, hazard analyses, and design mitigations
Experience creating reliability plans, teaching reliability principles to team members, and implementing a Design for Reliability program within a cross-functional team
Experience in designing and assessing compliance to national/international standards
Experience with designing fault-tolerant systems
Demonstrated leadership skills leading cross-functional Reliability programs
Proven ability to communicate in both verbal and written form to technical and non-technical customers, stakeholders, and various levels of management
Strong statistics and data analysis skills
Customer focus
Solution-oriented, even when all information is not known
Curious, smart, and creative
Positive attitude and strong team ethic
Strong sense of ownership
Excellent communicator and mentor
Ability to lift 25 pounds, with or without accommodations
Preferred
MS degree preferred
Experience with the following standards is preferred, but not required: ISO 14971, IEC 60601-1, IEC 60601-2-37
Benefits
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
You can accrue up to three (3) weeks of PTO in your first year of employment
PTO increases based on years of service
Four (4) additional paid days off, based on date of hire in the calendar year
Eight (8) paid holidays per year
Company
FUJIFILM Holdings America Corporation
For over 90 years, Fujifilm has found #ValueFromInnovation through expanding its portfolio to represent a broad spectrum of industries including medical and life sciences, electronic, chemical, graphic arts, information systems, industrial products, broadcast, data storage, and photography.
10001+ employees
H1B Sponsorship
FUJIFILM Holdings America Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2022 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2006-06-13Acquired
Leadership Team
Deepak Mahulikar
Chief Technology Officer
Patrícia Colombo
Chief Compliance Officer
Company data provided by crunchbase