Senior Systems Engineer

Fujifilm • Bothell, WA

8d • $110,000 - $160,000

About The Position

The Sr. Systems Engineer is a key contributor, providing leadership and expertise in driving new and sustaining engineering product deliverables through all development phases. The Sr. Systems Engineer will leverage quantitative approaches for design, system, and technology integration activities to demonstrate visible and measurable progress for successful delivery as defined within Fujifilm Sonosite’s Product Development Process (PDP) and in compliance with FDA CFR and ISO/IEC guidelines. The person in this position will participate in the leadership of R&D from within the cross-functional team that identifies opportunities, collaborates with external partners, develops and manages requirements, generates system architectures and component concepts, implements the solutions in hardware and software, analyzes data, and ensures robust verification and validation testing along with cost, risk, and lifecycle management.

Requirements

• 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 7-9 years of R&D experience with a proven track record of leading a team of Systems, BME, SW-E, ME, 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.
• Experience designing products and processes per industry standards; exposure to medical device safety standards (IEC 60601-1, etc.) is highly desired.
• Ability to lift 25lbs with or without accommodations.
• Excellent written and verbal communication skills.
• Strong interpersonal skills to work with other groups in an effective manner.
• Strong analytical skills.
• 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.
• Handle open-ended problems & ambiguity well.

Nice To Haves

• Experience designing and developing system architectures is a plus.
• Knowledge of medical device risk management per ISO 14971 is preferred.

Responsibilities

• Lead 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 technical product deliverables (DHF).
• Communicate effectively with multidisciplinary teams to monitor project progress, manage critical path activities, and ensure adherence to project milestones and timelines. Communicate project status through verbal and written reports as needed to Senior Management.
• Facilitate engineering change request quorum to manage the project scope and defects.
• Work with Quality and Regulatory Affairs to support regulatory activities specifically related to the introduction of new products (i.e., country registrations, submission and follow-up of 510k), as well as responding to internal and external audits (i.e., FDA, ISO, other regulatory bodies).
• Participate in post-market investigations as needed.

Benefits

• Medical, Dental & Vision
• Life & Company paid Disability
• 4% automatic Company contribution to 401k
• Fujifilm matches 50 cents for every dollar you contribute, up to 6% of your salary
• Accrue up to 120 hours of PTO in your first year of employment
• PTO increases based on years of service
• 32 hours additional paid time off for Employee Choice Holidays
• Eight (8) paid holidays per year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior