FUJIFILM
Reliability Engineer (Medical Device Industry)
FUJIFILM, Bothell, Washington, United States, 98021
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. Essential Job Functions
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. Knowledge/Experience
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. Skills/Abilities
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 information is incomplete 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. Salary and Benefits
$104,000.00 - $115,000.00/yr. depending on experience 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 salary Paid Time Off: accrue up to three (3) weeks in first year; PTO increases with years of service Employee Choice Holidays: four (4) additional paid days off Paid Holidays: eight (8) paid holidays per year FUJIFILM Sonosite offers a comprehensive compensation package, benefits, and a 401k program. To apply and obtain further details regarding key responsibilities and experience requirements, check 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. Resumes submitted by search firms/employment agencies will be deemed the property of FUJIFILM unless engaged by FUJIFILM for this requisition with a valid agreement in place. If a candidate submitted outside of the agency engagement process is hired, no fee will be paid. #CB #LI-MW EEO Information
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national or social origin, disability, veteran status, etc. ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (ffss-hr@fujifilm.com or (425) 951-1200).
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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. Essential Job Functions
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. Knowledge/Experience
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. Skills/Abilities
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 information is incomplete 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. Salary and Benefits
$104,000.00 - $115,000.00/yr. depending on experience 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 salary Paid Time Off: accrue up to three (3) weeks in first year; PTO increases with years of service Employee Choice Holidays: four (4) additional paid days off Paid Holidays: eight (8) paid holidays per year FUJIFILM Sonosite offers a comprehensive compensation package, benefits, and a 401k program. To apply and obtain further details regarding key responsibilities and experience requirements, check 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. Resumes submitted by search firms/employment agencies will be deemed the property of FUJIFILM unless engaged by FUJIFILM for this requisition with a valid agreement in place. If a candidate submitted outside of the agency engagement process is hired, no fee will be paid. #CB #LI-MW EEO Information
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national or social origin, disability, veteran status, etc. ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (ffss-hr@fujifilm.com or (425) 951-1200).
#J-18808-Ljbffr