Job Description
Job Description
Job Description
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This individual will contribute to the development and launch of exciting new drug / device combination products.
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As a Systems Engineer, you will be responsible for the integration of multiple disciplines to ensure robust patient-centric product design and performance.
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It is expected that you will create and manage project schedules and help identify project risks and develop mitigation plans.
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Responsible for working across engineering teams to lead and drive the following: User and Stakeholder Needs Definition, Use Case Analysis, traceability, Standards Coverage Analysis, System/Sub-System Requirements Definition, integration of third-party development activities, System Architecture & integration, Risk Management Planning and reporting, System Risk Assessment, Use Error Risk assessments, integration of drug product development activities, and design validation.
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Support in contributing to broadening the understanding and implementation of appropriate systems engineering principles
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Responsible for providing technical leadership in your areas of responsibility and ensure the systems design and documentation meet all safety and regulatory compliance requirement.
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Strong analytical and decision-making skills; self-driven and proactive in approach.
Qualifications
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Bachelor's Degree or equivalent education and typically 5-10 years of experience, Master's Degree or equivalent education and typically 3-7 years of experience, PhD and typically 1-4 years of experience; depending on the title Systems Engineer II or Systems Engineer III.
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Possess thorough theoretical and practical understanding of own scientific discipline.
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Effective writer and communicator of research or other regulatory materials.
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Leadership experience is required that includes the ability to influence and negotiate internally and externally.
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Product development experience in regulated industry (like Medical Device, Pharma & Biotech) required.
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Expertise in design and development processes that conform to standards including IEC 60601, ISO 14971, IEC 62304, 11608, 11040, and the ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820 and MDR.
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Experience is required in user and stakeholder need definition; requirements definition; risk management, product architecture.
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Include strong analytical, decision making and communication (spoken and written) skills.
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Strong organizational, facilitation, and communication skills with the ability to influence across a matrixed organization and manage competing priorities.
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Expertise in DHF management and creating various Design Control documents in compliance with applicable regulations.
California Fair Chance Act:
Synectics Inc. will consider qualified applicants with a criminal history pursuant to the California Fair Chance Act. You do not need to disclose your criminal history or participate in a background check until a conditional job offer is made to you. After making a conditional offer and running a background check, if Synectics Inc. is concerned about conviction that is directly related to the job, you will be given the chance to explain the circumstances surrounding the conviction, provide mitigating evidence, or challenge the accuracy of the background report. Find out more about the Fair Chance Act by visiting calcivilrights.ca.gov/fair-chance-act/.
Benefits:
Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.
Synectics is an equal opportunity employer.
\nCompany Description
Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities
Company Description
Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities