Job Description
Job Description
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The company is looking for a Systems Engineer to join their Product Development, Sciences and Technology (PDS&T) team in Operations. This individual will contribute to products that support making a remarkable impact on people’s lives. As a Systems Engineer, you will be responsible for integration of inputs and risks from multiple disciplines to ensure the development of a robust patient-centric product design and with reliable performance.
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Core Job Responsibilities:
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You will be a core member of the sustaining and new product introduction (NPI) teams, responsible for the implementation of appropriate product development engineering principles within the Design Controls process with particular focus on Design Inputs, Risk Management, Traceability, and Design Validation.
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You will be responsible for driving the following activities/deliverables:
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User and Stakeholder Needs Definition
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System/Sub-system Requirements Definition
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System Architecture & Integration
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Use Case Analysis
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Traceability
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Standards Coverage Analysis
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Risk Management Planning and reporting
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System Risk Assessment
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Use Related Risk Assessments
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Design Validation Planning, protocols, and reports
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Qualifications
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You will be responsible for providing technical leadership in your areas of responsibility and ensuring the systems design and documentation meet all safety and global regulatory compliance requirements.
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It is expected that you will work with the development team to resolve key project hurdles and to identify, communicate, and mitigate project risks.
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Expertise in product development from initial concept to release to market is required with experience in combination product or medical device development and familiarity with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO 14971, ISO 13485 and EU MDR preferred.
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Experience with various Systems Engineering activities including user and stakeholder need definition; requirements definition and management; risk management, product architecture, configuration management, traceability, change management and design validation.
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The candidate must have strong analytical and communication skills and should be self-driven.
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It is expected that you will continuously look for opportunities to simplify the ways we work to enable development efficiency without compromising quality.
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Experience:
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BS in Engineering, Science, or closely related discipline with 8-10 years of experience or MS or higher with 5-7 years of experience
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Ability to multitask and work within timelines.
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Demonstrated scientific writing skills and strong verbal communication skills.
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Work in an independent manner under the guidance of a supervisor or technical lead.
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Complies with applicable policies and procedures, regulatory and safety requirements.
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EEO:
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“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
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