Cutera Cutera
Cutera.com

R&D Compliance Project Engineer

Brisbane, US

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R&D Compliance Project Engineer Brisbane, CA, US

Job Description

We are seeking an outstanding R&D Compliance Project Engineer with strong quality and compliance testing knowledge to support our products through all phases of development. Programs involve a broad range of technologies including sophisticated laser and optical delivery systems, radio-frequency, and ultrasound devices. The ideal candidate will have a strong technical background with experience working with R&D in a compliance function for a regulated industry. Reporting to the PMO, this position liaisons heavily with R&D, Quality and Regulatory functions at Cutera as well as testing agencies.  As such, it provides an excellent opportunity for growth and visibility within Cutera.

Responsibilities

  • Support Program Management function in handling product development programs from proof-of-concept through production
  • Provides guidance and leadership for Compliance on various projects to ensure the fulfillment of regulatory requirements and objectives
  • Development and maintenance of a compliance documents such as - Critical components list, test reports, product specifications, risk management files, etc,... 
  • Leads and facilitates projects for the development, maintenance, and improvement of various compliance documents
  • Lead communication with the testing agency for regulatory testing
  • Support facility inspections and audits as required by government and regulatory agencies on a global basis.
  • Shares responsibility with Regulatory Compliance on maintaining audit readiness for internal and external audits
  • Liaison between R&D, Quality, Regulatory functions at Cutera and testing agencies (TUV, UL, Intertek) 
  • Maintain Design History Files for all products (DHF)

Qualifications

  • Familiar with applicable US medical device regulations (e.g., 21 CFR Part 820, 21 CFR Part 11), international standards (e.g., ISO 13485, ISO 14971), and international regulations (e.g., CMDR – Canada, European, RDC – Brazil), IEC standards - 60601, 62304, & 62366 [advanced training supplied]
  • Demonstrated strong leadership and partnership in working with diverse teams for improvements, issue resolution, or projects
  • Experience in developing and implementing processes and procedures to comply with regulations and standards across an organization
  • Strong organizational, written, and verbal communication skills; plus critical thinking skills and proficiency in constructive dialogue
  • Familiar with risk management, CAPA, and internal/external audit methodologies

Education & Experience

  • Minimum Bachelor Degree – BS degree in Engineering, Physical or Biological Science, or other technical field. Electrical Engineering preferred.
  • Five plus (5+) years’ experience in compliance, medical device preferred

Additional information

Please visit www.cutera.com for more information about Cutera.

We seek extraordinarily capable, and committed people to help shape and develop our Company. We offer competitive benefits to all levels of employees and provide free shuttles to and from nearby BART and Caltrain stations. If this hands-on leadership positions seems like an exciting role, then apply today! 

We design, develop, manufacture, and market medical instruments used in dermatology for advanced energy-based medical aesthetic solutions. Founded in 1998, the corporate headquarters for the Company is located in Brisbane, CA (just outside of San Francisco) and we are proud to manufacture all of our systems and accessories at our headquarters.

All your information will be kept confidential according to EEO guidelines.

If you are ready to become part of our spectacular, growing, and FUN company, then apply today!

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.

Applicants responding to this posting must be able to provide proof of eligibility to work in the United States. Competitive salary, benefits, ESPP and stock options. Cutera is an Equal Employment Opportunity Employer.

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Job Location

Department: R&D

City: Brisbane, CA, US

Employer reference: REF436O

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