Position OverviewThe 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.
Job DescriptionEssential Job Functions:- 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.
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 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.
- Experience designing and developing system architectures is a plus.
- Demonstrated ability to understand clinical scenarios, conceptualize technical solutions, explain concepts to implementation engineers, test and evaluate designs and prototypes.
- 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:- 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.
Salary and Benefits:- $110,000/yr. - $160,000/yr. depending on experience + variable target bonus (Compensation will vary based on skills, experience and location; it is not typical to be hired at or above the top of the salary range).
- 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 your salary
- Paid Time Off:
- You can accrue up to 120 hours of PTO in your first year of employment
- PTO increases based on years of service
- Employee Choice Holidays:
- 32 hours additional paid time off, based on date of hire in the calendar year
- Paid Holidays:
- Eight (8) paid holidays per year
FUJIFILM Sonosite offers a fantastic compensation package, including benefits, and a 401k program. Visit us today to learn more about our exciting technologies and how you can make a difference. To apply and obtain further details regarding key responsibilities and experience requirements, check out our careers page at www.Sonosite.com/about/careers.
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