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Product Safety Engineer

Company:
Dhanu Global Enterprises, Inc
Location:
Minneapolis, Minnesota, United States
Posted:
November 08, 2018

Description:

Product Safety Engineer

Product Safety engineer to provide support for R&D and Operations for project Hawk to ensure compliance to global safety requirements, conduct and coordinate safety testing, drive safety design reviews, provide support to external test houses, serve as a direct interface and facilitator between development team and CSA, UL, ETL, etc., create and maintain appropriate reports and related documents.

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree, or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience.

• Provide support & consultation for R&D and Operations for project Hawk to ensure compliance to global safety requirements.

• Assist product development team with the technical understanding of the IEC60601-1 (Medical Product Safety) and related standards.

• Carry out design analysis to support the development of products within the boundaries of safety standards. Assist in identification, analysis, and control of conditions impeding product safety.

• Support change management activities.

• Conduct and coordinate safety testing, including EMI/EMC and Wireless Compliance, on existing and new products to ensure safety compliance according to IEC 60601-1-2, and evaluate test results.

• Conduct root cause analysis and implement due diligence actions to resolve product issues.

• Drive safety design reviews with the project teams

• Provide support to external test houses during product evaluations.

• Serve as a direct interface and facilitator between development team and CSA, UL, ETL, etc.

• Create and maintain appropriate reports and related documents.

Skills Desired:

• Being highly organized and capable of tracking multiple project tasks through various stages of development.

• Excellent analytical skills.

• Demonstrated mechanical/electrical problem-solving skills.

• Strong technical leadership, communication, planning & organization skills with great work ethic.

• Experience with medical devices is very beneficial

• Working knowledge of CSA, EN, IEC and other regulations and standards relating to Medical (60601) products is desired

• Being a resourceful, hands-on, problem solving individual with initiative and drive to work around administrative and technical obstacles.

• Experience in supporting internal and external audits is helpful.

• Good interpersonal communication skills.

Bachelor’s degree needed as the position will be technical. - Electrical Engineering or Biomedical with EE concentration preferred

Top 3 Must-Haves:

1. Being highly organized and capable of tracking multiple project tasks through various stages of development.

2. Being a resourceful, hands-on, problem solving individual with initiative and drive to work around administrative and technical obstacles.

3. Strong technical leadership, communication, planning & organization skills with great work ethic. Top

3 Nice-To-Haves:

1. Experience with medical devices is very beneficial

2. Working knowledge of CSA, EN, IEC and other regulations and standards relating to Medical (IEC60601) products is desired

3. Demonstrated mechanical/electrical problem-solving skills. - Excellent analytical skills. - Experience in supporting internal and external audits is helpful. - Good interpersonal communication skills.