Reliability Engineer (Medical Device Industry)

FUJIFILM Diosynth Biotechnologies•Bothell, WA

37d•$104,000 - $115,000

About The Position

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 be a champion and focal point on new product development teams using a Design for Reliability (DfR) approach starting early in the design process to ensure designs are robust to customer use, environmental stress, and service-life duration. The position will also support released products with failure rate analyses, reliability improvement projects, and safety risk assessments of field failure issues. You will work collaboratively within a technical cross-functional team to plan Design for Reliability efforts, including reliability analyses, HALT tests, reliability demonstration test programs, and engineering analyses. This position involves strong partnership with Hardware Engineering, Software Engineering, Program Management, Quality, Supplier Quality, and Manufacturing to lead, champion, and act as focal point for the reliability aspects of assigned projects. At 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."

Requirements

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.
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.
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.

Nice To Haves

MS degree preferred
Experience with the following standards is preferred, but not required: ISO 14971, IEC 60601-1, IEC 60601-2-37.
Experience in designing and assessing compliance to national/international standards.
Experience with designing fault-tolerant systems.

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.

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
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