Systems Engineer

Systems Engineer/Sr. Systems Engineer

JOB SUMMARY

Senior systems engineer translates the user needs and business needs into the specifications that drive design, implementation, testing of products that are used for collection of blood and blood components. Senior systems engineer will practice design controls in compliance with the quality management systems to deliver on products that are effective, safe and compliant. In this role you are expected to coordinate the design activities in collaboration with various stakeholders including mechanical, electrical, software, quality, manufacturing and commercial Teams. As a senior systems engineer you are expected to independently conduct design change impact assessment, coordinate technical reviews of the changes, conduct failure analysis and potential risk impact assessment as part of a cross-functional Team.

ESSENTIAL DUTIES

• Translate 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 quality
• Communicate 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 plans
• Create, 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 RESPONSIBILITIES

• Work 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

Education

• Bachelor’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.

Experience

• Minimum 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.

Skills

• Proficient in configuration management for complex medical device platforms including hardware, software and disposables
• Knowledgeable in evaluating designs for serviceability and manufacturability
• Practice the creation, maintenance of Design History files for medical device products
• Awareness of EUMDR, FDA QSR for technical documentation, labeling and clinical evaluation
• Develop and oversee test methods to demonstrate the design has implemented the necessary functionality
• Conduct design analysis necessary to evaluate the completeness of specifications, testing
• Utilize failure analysis to determine if the designs are effective in meeting the user and business needs
• Evaluate the designs for serviceability and manufacturability
• Mentor junior engineers on the practice of systems thinking
• Manage projects independently to lead changes to existing features and incorporate new features for the product platforms used in collecting blood and blood components
• Experience in conducting risk analysis for defects to demonstrate the safety and efficacy of medical device platforms
• Proficient in using requirements management tools like Doors, Windchill RV&S
• Proficient in using test management tools like ALM for test case management
• Experience in using SysML for describing the complex design using tools like CATIA Magic Cyber Systems Engineer, PTC Modeler or Enterprise Architect.

PHYSICAL REQUIREMENTS

General 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 Requirements

Requires travel based on business needs.

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