Job Description

In this role as a Sr. Systems Engineer, you will have responsibility for contributing to the development of medical device products from early feasibility through to market release. You will act as an influential systems engineer working within a matrix organization to support the Systems Engineering organization in the definition, design, development, and testing of complex medical device systems. These products provide therapy for a variety of conditions including Chronic Pain, Cancer Pain, Severe Spasticity, Epilepsy, Dystonia, Essential Tremor, and Parkinson's Disease.

You will work closely with a cross-functional engineering team to synthesize feature needs and technology trends into system requirements and design specifications. Typical system designs involve complex electronic circuits, wireless communication, batteries and a mix of consumer and medical technologies. Systems are designed with the user in mind to provide innovative solutions in the marketplace. This individual will apply proven communication skills, problem-solving skills, and knowledge of best practices to guide his/her team on issues related to the design, design characterization and verification testing, operations support, and product release.

Responsibilities may include the following and other duties may be assigned:

• Collect and analyze design inputs (customer needs, business needs, etc.) and transform them into high quality engineering requirements.
• Perform system architecture and design for all phases of system development to include: concept, design, fabrication, test, installation, operation, maintenance and disposal.
• Ensure the logical and systematic conversion of system requirements and design into product requirements that acknowledge technical, schedule, and cost constraints.
• Performs functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications.
• Lead, coordinate, execute, and document system analysis and design activities including but not limited to architecture definition, interface management, performance modeling, system integration, and design failure modes and effects analyses.
• Identify technical development risks, develop, and execute risk burn-down plans
• Facilitate cross-functional engineering and project team communication to drive design decisions, align on test and integration strategies, review test results, identify technical issues and manage their resolution
• Support regulatory body submissions and facilitate knowledge transfer to continuation engineering teams
• Represent the organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. May negotiate with others to reach understanding or agreement, and influence decision-making.
• Manage moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.
• Provide guidance, coaching, and training to other employees within job area.
• Establish and advocate for best practices and continuous improvement as to mature the Systems Engineering knowledge and processes.

Skillsets:

• Experience developing system definition, system design and requirements, requirement tracing to subsystems and interface requirements, and system verification and validation strategy and testing.
• Previous medical device experience with a history of developing products from technology to market release
• Experience with designing for the Hardware/Firmware/communication interfaces of electronic devices
• Experience in troubleshooting firmware/software interfaces
• Product Risk Assessment and Risk Management Experience (Fault Tree Analysis, Failure Modes, and Effects Analysis, etc.)
• Experience working with and designing systems to meet ISO and Quality System Regulation requirements, including IEC-60601-1, -2, -6, IEC-62304, ISO-14971, FDA 21CFR820.30 for Class I, II and III medical systems
• Demonstrated strong verbal/written communication
• Demonstrated ability to make decisions quickly and guide a team through complex problems
• Experience working in cross-functional and team environments
• Experience working in FDA regulated and/or medical device environment

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