Reliability Engineer; Medical Device Industry

Overview

Fujifilm Sonosite is seeking a Reliability Engineer to support R&D Systems Engineering developing Point-of-Care ultrasound medical devices in Bothell, Washington. As an individual contributor, you will support the entire lifecycle of ultrasound systems, including transducers and accessories. This position will champion and act as focal point on new product development teams using a Design for Reliability (DfR) approaches to ensure designs are robust to customer use, environmental stress, and service-life duration.

The role also supports released products with failure rate analyses, reliability improvement projects, and safety risk assessments of field failure issues. You will work with a cross-functional team to plan reliability efforts, including reliability analyses, HALT tests, reliability demonstration test programs, and engineering analyses, in partnership with Hardware Engineering, Software Engineering, Program Management, Quality, Supplier Quality, and Manufacturing.

FUJIFILM Sonosite is headquartered in Bothell, WA, with a broader global presence and a focus on point-of-care ultrasound technology and life-saving innovations.

• Work hand in hand with Program Management, Product Management, and discipline leads to ensure the overall product/solution system integrity from concept to end of life, including meeting stakeholder expectations (Systems Engineering, Manufacturing, Quality, regulatory bodies, Servicing, 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 design areas and demonstrate product reliability prior to 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 UI, 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.

• BS in relevant engineering, statistics, or data analysis field (MS degree preferred).
• 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.
• Experience with standards such as ISO 14971, IEC 60601-1, IEC 60601-2-37 (preferred but not required).
• In-depth understanding of both hardware and software for integrated products, including 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.
• Str…