FUJIFILM Sonosite, Inc. · 1 month ago
Senior Compliance Engineer
Bothell, WA
Full-time
Onsite
Mid, Senior Level
$97K/yr - $125K/yr
6+ years expFUJIFILM Sonosite, Inc. is a leader in point-of-care ultrasound technology, dedicated to improving healthcare delivery. The Senior Compliance Engineer will provide global product compliance analysis and guidance, ensuring adherence to regulatory performance specifications while managing compliance plans and addressing compliance issues.
Medical Device
Responsibilities
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
Qualification
Required
BS Engineering or Physics
6-8 yrs 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
Ability to lift a minimum of 25lbs with or without accommodations
Preferred
Familiarity with MS Project and Agile Change Management strongly preferred
Benefits
Medical, Dental & Vision
Life & Company paid Disability
4% automatic Company contribution
Fujifilm matches 50 cents for every dollar you contribute, up to 6% of your salary
You can accrue up to three (3) weeks of PTO in your first year of employment
PTO increases based on years of service
Four (4) additional paid days off, based on date of hire in the calendar year
Eight (8) paid holidays per year
Company
FUJIFILM Sonosite, Inc.
As an innovator in point-of-care ultrasound, we imagine a world without barriers, empowering clinicians with immediate answers for any patient, anywhere, anytime.
501-1000 employees
H1B Sponsorship
FUJIFILM Sonosite, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (2)
2023 (1)
2022 (5)
2021 (7)
2020 (3)
Funding
Current Stage
Late StageLeadership Team
Richard Fabian
Chief Executive Officer
Recent News
2025-08-14
Company data provided by crunchbase