Systems Engineer III at Fujifilm

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 Systems Engineer III reports to the Manager of Systems Engineering and operates with the guidance of a Senior Systems Engineer, focusing on understanding and capturing customer needs; product functional and performance requirements; product architecture, constraints and trade-offs; design requirements; safety risk management; and technical risks for new product developed and sustaining legacy products. This role works in close collaboration with the project lead on assigned tasks with minimal supervision and provides inputs to product design, cost, and schedule. This role also engages in design reviews and helps resolve design challenges. They must exhibit an ability to grow in their understanding of product domain, organizational dynamics, and formal methods for Systems Engineering. They are expected to have a mastery of one or more tools used within the system engineering process and to assist others in their use. They shall specifically demonstrate an ability to maintain and streamline the requirements management infrastructure from a technical tools perspective as well as the associated processes. It is expected that they can deliver high quality work items according to their committed schedule.

Essential Job Functions:

• Support cross-functional project teams in the design and development of medical imaging systems through phase gate product development process from concept to launch.

• Ensure that products and processes comply with applicable industry guidance, standards, and regulations.

• Work with clinicians, end users, and marketing to define and evaluate new innovative product concepts to address unmet customer and business needs.

• Support sustaining engineering initiatives for the strategic products manufactured in-house or at contract manufacturing sites.

• Support program management with strong project management skills to effectively manage the systems engineering-related deliverables.

• Communicate effectively with multidisciplinary teams to monitor project progress, manage critical path activities, and to ensure adherence to project milestones and timelines. Communicate project status through verbal and written reports as needed to Senior Management.

• Participate in post-market investigations as needed.

Knowledge and Experience:

• An undergraduate degree in an engineering or science discipline (Biology, Biomedical Engineering, Chemistry, Chemical Engineering, Material Science, Mechanical Engineering, or other related discipline); Graduate Degree is a plus.

• Minimum of 5 years of R&D experience with a proven track record of working within a team of Systems, BME, ME, SW-E and/or EE engineers in the development and commercialization of products within a regulated industry, preferably medical imaging.

• Demonstrated ability to: understand clinical scenarios, conceptualize technical solutions, explain concepts to implementation engineers, test, and evaluate designs and prototypes.

• Excellent communication skills including an ability to influence at all levels of the organization.

• Knowledge of medical device risk management per ISO 14971 is preferred.

• Experience designing products and processes per industry standards; exposure to medical device safety standards (IEC 60601-1, etc.) is highly desired.

Skills and Abilities:

• Excellent written and verbal communication skills.

• Strong interpersonal skills to work with other groups in an effective manner.

• Organizational skills to synthesize many inputs to create and communicate the big picture and make necessary decisions.

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

Salary and Benefits:

• $78,000- $115,000 + variable bonus opportunity

• Insurance:

o Medical, Dental & Vision

o Life & Company paid Disability

• Retirement Plan (401k):

o 4% automatic Company contribution

o Fujifilm matches 50 cents for every dollar you contribute, up to 6% of your salary

• Paid Time Off:

o You can accrue up to three (3) weeks of PTO in your first year of employment

o PTO increases based on years of service

• Employee Choice Holidays:

o Four (4) additional paid days off, based on date of hire in the calendar year

• Paid Holidays:

o Eight (8) paid holidays per year