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Sr Systems Engineer
7000 Central Avenue Northeast Fridley, MN 55432 US
Job Description
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
- 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
- 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.
- Understand and advocate for technology evolution and participate in the development of system and product roadmaps.
Nice to Have
- 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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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