Senior Compliance Engineer

Sr. Compliance Engineer

At Fujifilm Sonosite, we are looking for an experienced Sr. Compliance Engineer who will be responsible for providing global product compliance analysis and guidance to ensure that all electrical, mechanical and other regulated performance specifications are satisfied in all countries where Fujifilm Sonosite's business exists or will expand. You will be part of a Regulatory Compliance team that conducts global due diligence for product compliance requirements, monitors emerging regulations and new standards, develops compliance specifications and policies, builds compliance programs to support Fujifilm Sonosite's business initiatives, and troubleshoots and resolves compliance issues that arise in the course of business.

Job Description

Essential Job Functions:

• 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.

Knowledge and Experience:

• 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.

Skills/Abilities:

• 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 25lbs with or without accommodations.

Salary and Benefits:

• $97,000 - $125,000 depending on experience + variable bonus opportunity.
• 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 three (3) weeks of PTO in your first year of employment; PTO increases based on years of service.
• Employee Choice Holidays: Four (4) additional paid days 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.