As a Senior Systems Engineer with Altran, you will be a primary technology lead for a multi-disciplinary project team responsible for the maintaining complex, software-driven electromechanical products.
You will act as a central source of product knowledge, drive evaluation and decisions about product changes, and be responsible for the requirements and risk management activities for several products.
You will support system-level evaluations of product issues and drive their resolution through investigation, root cause analysis, evaluation of risks and impacts.
· Analyze and comprehend product specifications to ensure product and project compliance.
· Develop and manage requirements traceability matrix (RTM)
· Document component and subsystem specifications and material requirements
· Apply knowledge of multiple engineering disciplines to evaluate complaints or other sources of issues raised regarding proper function of complex systems, subsystems or assemblies, leading to the resolution and closure of corrective and preventative actions within a concurrent engineering environment
· Complete system analysis and design analysis as necessary, i.e. risk analysis, safety analysis, FMEA, etc.
· Ensure verification of product or subsystem performance in order to prove the technical design through inspection, analysis, simulation and test
· Specify and evaluate supplier components, subsystems and services
· Communicate clearly (written and oral) with program management and the customer as required
· Provides technical expertise and assistance to other engineers and support personnel
· Interact with technical management, other professionals, technicians and support personnel to coordinate, recommend and confer regarding technical activities and progress
· Able to function as both an individual contributor and as a senior technical lead when required
· Strong preference for experience with regulated design and development processes that conform to standards such as ISO 9, ISO 13485, ISO 14971, IEC 62304, DO-178, DO-254
· Excellent project team skills; experience and capability working collaboratively in a client environment per the client’s Quality Management System (QMS), as part of a cross-functional team that includes development/verification/validation/procurement/manufacturing/regulatory and quality experts
· Strong verbal and written communication skills to aid interactions within Engineering, otherinternal departments and external customers
· Detail oriented, highly organized, and able to effectively multitask and handle changing work assignments, schedules, and priorities
· Extensive PC skills in Word, Excel, Power Point, Outlook, Windows, etc.
· Demonstrated experience in customer-facing situations where the ability to distinguish between the need to listen and the need to drive the conversation is paramount
· Familiarity with Systems Engineering practices such as requirements management, design trade-off and cost-benefit analysis, hazards and risk assessments
· Experience with requirements management and application/product lifecycle management tools and infrastructure
· Experience working in a highly regulated product development environment such as medical devices or aerospace
· Experience using one or more ALM/PLM tool suites
· Prior experience with DOORS
· Experience developing medical products using various accepted standards (ISO, IEC, CFR, etc.)
· Experience with PMA and/or 510(k) submission processes
· Position may require up to 25% travel, domestic and international
- Master’s Degree in Engineering or equivalent education and experience
- 8+ years of detailed design experience related to medical, aerospace or commercial products
- Domain expertise in one of more associated domains; preferably Electrical, Software Engineering, or Mechanical Engineering with exposure to Quality, and Test Engineering