Senior Compliance Engineer

Senior Compliance Engineer

FUJIFILM Sonosite, Inc.

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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.”

• Work closely with other Regulatory Compliance team members to review proposed and final standards and product regulatory changes for technical impact to products.
• Lead and communicate this impact to stakeholders and customers and manage compliance plans for these updated standards and regulations from a technical standpoint.
• Deep dive product compliance standards including, e.g., electrical product safety, EMC, RF, and telecommunications standards.
• Finalize and update procedures and guidelines to mitigate compliance issues early in the design phase, and ensure that devices meet governmental and industry regulations in international markets.
• Identify and interpret relevant compliance standards against which to test hardware, based on specific use cases.
• Maintain in‑house test capability for demonstrating compliance to IEC 60601‑1 general safety and system safety that meets CSA SMT requirements.
• Provide proposal, planning, and implementation for in‑house EMC testing prior to external testing.
• Be current on any changes to relevant global agency approvals and testing procedures.
• Develop key metrics to evaluate the program’s performance, and build implementation plans to confirm our performance and compliance, against program metrics, internal company requirements, and regulations; conduct periodic reviews to ensure projects are on track.
• Oversee planning and scheduling of compliance engineering activities to program management.
• Obtain other safety approvals, as required to support market requirements. Provide support for submissions made by Regulatory Affairs.
• Release compliance verification plans and reports showing that applicable FRS requirements are met for general safety, system safety, ultrasound safety, EMC, and biocompatibility.
• Assist in technical risk management and assessment.

• BS Engineering or Physics.
• 6–8 years in compliance or test engineering. Knowledge and test experience with respect to IEC 60601‑1 medical equipment safety standards including general safety, system safety, and EMC is strongly preferred.
• 2+ years leadership role working with line departments in a manufacturing environment.
• ISO, FDA, or other regulated industry training and experience.
• Risk assessment experience.

• Excellent written and oral communication skills.
• Able to provide either leadership or a supportive role within a project team.
• Able to coordinate and manage multiple tasks simultaneously.
• Familiarity with MS Project and Agile Change Management strongly preferred.
• Ability to lift a minimum of 25 lbs with or without accommodations.

• $97,000 – $125,000 depending on experience + variable bonus opportunity (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…