Systems Engineer III

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Company: Takeda

Location: San Diego, CA 92154

Description:

This role is responsible for using their broad technical expertise, leadership skills, and product development knowledge to provide Systems leadership through various phases of the product life cycle. System Engineering translates the 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 an Engineer III, 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 milestones are met and systems integration activities are identified and fulfilled.

Essential Functions:
Working knowledge of product development lifecycle, concept through launch
Leads system/product-level feasibility and risks assessments
Facilitates cross-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
Identifies opportunities and drives continuous improvement efforts
Applies DFSS best practices 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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Required Skills & Experience
- Bachelor's degree in Science or Engineering (postgraduate degree preferred).
- Minimum of 5 years of the follow experience:
- Systems Engineering in the medical device development, or similar fields.
- Experience with requirements management, systems integration, and testing.
- Understanding of compliance with IEC standards
- Strong implementation of Basic Safety and EMC Standards e.g. 60601-1, 61010-1, 60601-1-24

Nice to Have Skills & Experience

Good understanding of ISO 15223-1 and ISO 20417
Quality Management System in SAP

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

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