Systems Engineer II
Medtronic
full-time
Posted on:
Location Type: Office
Location: Fridley • Minnesota • 🇺🇸 United States
Visit company websiteSalary
💰 $83,200 - $124,800 per year
Job Level
JuniorMid-Level
About the role
- Contribute to the development of Neuromodulation products from early feasibility through to market release.
- 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 within the Neuromodulation Operating Unit.
- Work closely with a cross-functional engineering team to synthesize feature needs and technology trends into system requirements and design specifications.
- 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.
- Perform 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
- Verify system requirements have been properly implemented (writing, leveling, tracing) through inspection, demonstration, test or analysis.
- Validate that implemented systems meet customer needs
- Support regulatory body submissions and facilitate knowledge transfer to continuation engineering teams.
- 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.
Requirements
- Bachelors degree in a technically related field required
- Minimum of 2 years of engineering experience or advanced degree with 0 years of experience
- 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
- Experience developing sensor-based systems, including closed-loop feedback control systems.
- Experience developing data analytics algorithms, and machine learning algorithms.
- 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
- Experience interfacing with physician customers and therapy consultants.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
system architecturesystem designrequirements tracingsystem verificationvalidation strategydata analytics algorithmsmachine learning algorithmsclosed-loop feedback control systemsFault Tree AnalysisFailure Modes and Effects Analysis
Soft skills
strong verbal communicationstrong written communicationdecision makingteam guidancecross-functional collaborationproblem solvingcoachingtrainingproject managementcontinuous improvement