System Engineer
1 week ago
ESSENTIAL DUTIESTranslate user and business requirements into detailed product requirement specifications and design specifications.Apply design controls with extensive knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366, and IEC 60601 for medical device development.Lead multidisciplinary design efforts to ensure seamless integration and timely delivery.Collaborate globally to integrate mechanical, electrical, and software components, achieving functional and reliability goals.Lead design changes to implement and enhance features for blood collection platforms, ensuring quality and regulatory compliance.Independently conduct technical reviews with stakeholders to meet project design objectives.Perform failure analyses to prioritize testing and ensure design completeness and product qualityCommunicate and collaborate effectively to align teams and streamline workflows.Support design transfer to enable successful commercialization of complex products.Use systems thinking to design complex platforms integrating equipment, software, and disposables.Apply knowledge of manufacturing processes tailored to diverse product types like electronics, mechanical design and plastics.Define and manage project scope to optimize resources and avoid scope creep.Lead defect management meetings to achieve actionable outcomes and maintain good documentation practices.Develop and approve test protocols to ensure functional testing and maximize reuse for multiple configurations.Apply Six Sigma and Lean principles to enhance efficiency and minimize waste.Define integration and verification plans with experience in budgeting adequate resources and time for execution of the plansCreate, maintain and release Design History File (DHF), Device History Record (DHR), Device Master Record (DMR)Conduct Technical reviews to root cause issues, perform tradeoff analysis, document key design considerations for future reference
OTHER DUTIES AND RESPONSIBILITIESWork direction responsibility may include technicians and junior engineers.May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.May contribute to the establishment of business objectives, goals, budgets, and costs.
MINIMUM QUALIFICATION REQUIREMENTS
EducationBachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.Bachelor of Science degree or Master of Science degree in Engineering preferred.
ExperienceMinimum of 7-9 years of engineering experience is required for a Senior System Engineer and 5-7 years of experience for a System Engineer.Minimum of four years systems engineering experience in the medical device field preferred for Sr. Engineer and 2 years experience for System Engineer.
SkillsProficient in configuration management for complex medical device platforms including hardware, software and disposablesKnowledgeable in evaluating designs for serviceability and manufacturabilityPractice the creation, maintenance of Design History files for medical device productsAwareness of EUMDR, FDA QSR for technical documentation, labeling and clinical evaluationDevelop and oversee test methods to demonstrate the design has implemented the necessary functionalityConduct design analysis necessary to evaluate the completeness of specifications, testingUtilize failure analysis to determine if the designs are effective in meeting the user and business needsEvaluate the designs for serviceability and manufacturabilityMentor junior engineers on the practice of systems thinkingManage projects independently to lead changes to existing features and incorporate new features for the product platforms used in collecting blood and blood componentsExperience in conducting risk analysis for defects to demonstrate the safety and efficacy of medical device platformsProficient in using requirements management tools like Doors, Windchill RV&SProficient in using test management tools like ALM for test case managementExperience in using SysML for describing the complex design using tools like CATIA Magic Cyber Systems Engineer, PTC Modeler or Enterprise Architect.
PHYSICAL REQUIREMENTSGeneral Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Additional Physical RequirementsRequires travel based on business needs.
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