Job Information
Insight Global Compliance Engineer in San Diego, California
Job Description
This Systems Engineer translates voice of customer and stakeholder needs into system and product requirements, identifies potential hazards, and assesses requirements to ensure that the product meets the user/business needs, develops design and process specifications for new hardware and software products, aids in product verification and validation, and provides support in sustaining activities. The expectation for a Senior Systems Engineer is that they regularly serve on smaller project core teams, act as a leader of technical excellence, and participate as an agent for continuous improvement within the Systems Engineering function. As such they are expected to help identify tasks/resources to ensure that critical project landmarks are met, and systems integration activities are identified and fulfilled.
A Senior Compliance and Systems Engineer in this role is responsible for using their broad technical expertise, leadership skills, and product development knowledge to provide Systems Engineering and Compliance support through different phases of product life cycle.
Essential Functions:
Working knowledge of product development lifecycle, concept through launch
Leads system/product-level feasibility and risks assessments
Provide compliance support throughout the product life cycle on product project teams (e.g. developing regulatory and compliance strategies, compliance assessments, work with NRTLs)
Facilitates multi-functional knowledge and experiences to promote the understanding and resolution of in-market and product development issues
Responsible for coordination of system-level product development and its integration
Serves as a resource to examine system behavior issues and bring to resolution for on-market products
Sees opportunities and drives continuous improvement efforts
Applies DFSS standard methodologies on all projects.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .
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Skills and Requirements
-Bachelor's degree in Science or Engineering (postgraduate degree preferred).
-Minimum of 5 years of the follow experience:
-Compliance or Test Engineering in the medical device development, or similar fields.
-Experience developing regulatory and compliance strategies, compliance assessments, work with NRTLs
-Understanding of Basic Safety and EMC Standards e.g. 60601-1, 61010-1, 60601-1-2 and ISO 15223-1 and ISO 20417 -Working experience with CSA Certifications
- QMS experience with SAP null
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.