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FUJIFILM Cellular Dynamics, Inc · 3 months ago

Senior Compliance Engineer

US-WA-Bothell

Full-time

Onsite

Mid, Senior Level

$97K/yr - $125K/yr

6+ years exp

Fujifilm Sonosite is a leader in bedside ultrasound systems, dedicated to reinventing healthcare delivery through technology. They are seeking an experienced Senior Compliance Engineer to provide global product compliance analysis and guidance, ensuring adherence to regulatory performance specifications across various markets.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

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

IEC 60601-1 complianceEMC testingRisk assessmentISO experienceFDA regulationsMulti-taskingMS Project familiarityAgile Change ManagementCommunicationProject managementTeam leadership

Required

BS Engineering or Physics

6-8 yrs in compliance or test engineering

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

Knowledge and test experience with respect to IEC 60601-1 medical equipment safety standards including general safety, system safety, and EMC is strongly 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 Cellular Dynamics, Inc

Fujifilm Cellular Dynamics, Inc. develops and manufactures biologically relevant human cells derived from induced pluripotent stem (iPS) cells.

Founded in 2004

Madison, Wisconsin, USA

51-200 employees

https://www.fujifilmcdi.com

H1B Sponsorship

FUJIFILM Cellular Dynamics, 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

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Trends of Total Sponsorships

2023 (4)

2021 (1)

2020 (3)