Medical Device - SR Systems Engineer (IEC 60601 ) Onsite R&D
Medical Device Princ/Senior Systems Engineer - R&D New Product Development------ Must have held the actual title of Systems Engineer before, with experience developing new Medical Devices (IEC 60601) ------------ Must work onsite 3 days a week in the office in either Providence, RI, Raleigh, NC, or Minneapolis, MNRole requires someone that has served in a similar capacity within the new product development life cycle of several medical devices (from concept, planning, prototype, testing, manufacturing, to commercialization, etc.
).
This Medical Device Principal or Senior Systems Engineer will be part of the New Product Development/R&D team and will drive product innovation processes through the synthesis of unmet needs, product definition, and systems level design.
The Systems Engineer is expected to contribute to technical research, concept development, and design across healthcare/medical device programs that require great communication skills to collaborate across internal and external teams.
The Medical Device Systems Engineer will oversee all of the different components that contribute to the end user's experience of a medical device.
These might include software, hardware, usability, interface design, manufacturing, quality, etc.
The job requires someone that has the ability to identify gaps in technical knowledge required to develop a new medical device and create a plan to pursue the information.
This person must be a curious technical researcher that enjoys open-ended ambiguous challenges.
The Senior Systems Engineer will lead systems-oriented design (defining and designing product architectures, functions, and uses) and manage deliverables within the established criteria.
The System Engineer may act as the technical lead on system definition and technical research programs or will act as the systems lead on multidisciplinary programs.
Systems Engineers are responsible for creating documentation to drive technical research, capture product requirements, system design visualization, and prototype test results.
Responsibilities Contribute during all phases of the new medical device Product Development cycle with particular emphasis on product definition, conceptualization, and verification.
Lead technical research processes, collecting and documenting research findings and articulating insights and recommendations.
Facilitate the organization and distillment of evolving product requirements including the translation of user needs and the definition of technical requirements.
Communicate with client teams to gather inputs, and collaborate on product definition to maintain team alignment.
Lead system design and architecture definition conceptualization; creating block diagrams, use cases, feature functional mapping and modeling.
Support new concept generation and design engineering with reference requirements and targeted technical research activities.
Contribute to Design Verification and risk management activities.
REQUIREMENTS:
Must have had the actual title of Systems Engineer in the R&D new product development group working on new medical devices (IEC 60601).
A minimum of7 or more years of Medical Device experience is required.
Must have great interpersonal and communication skills with the ability to transmit technical concepts to non-technical teams and clients.
Bachelors' degree is required, Masters is GREATLY preferred (in Biomedical Engineering, Mechanical, EE, or similar).
Most of the other peers in this position have at least a Masters' degree.
Some have PhDs.
Depending on years of relevant experience, the company could hire someone at the Senior or Principal or even Senior Principal-level.
Must have the ability to identify gaps in technical knowledge (required to develop a new medical device) and create a plan to pursue the information.
This person must be a curious technical researcher that enjoys open-ended ambiguous challenges.
Must have strong experience using a Requirement Management Tool (ex.
JAMA, Helix, Doors, or related) steering the new product development cycle for a medical device.
Must be great at creating documentation to drive technical research, capture product requirements, system design visualization, and prototype test results.
Must be comfortable working in a project-based, consultative services, start-up-like environment driven by client demands which determine deadlines, and change priorities often.
You must be able to work on 2, 3, or more projects at the same time.
Comfortable translating unmet user needs and driving process of translating synthesized user needs into product requirements and system architectures.
Working knowledge of common technology systems and manufacturing processes, such as injection molding, sheet metal fabrication, machined part design, etc.
is nice to have.
Experience estimating the effort and duration of tasks, informing program milestones and expectations is nice to have.
Proven experience exploring and concepting technical systems, with an ability to visualize and prototype concepts for evaluation and refinement.
The ability to look at the big picture (30 thousand feet-level) of the project to help trade off requirements and implementation.
Must be willing to work onsite 3 days a week, every week.
NO Visa sponsorship.
Recommended Skills Architecture Curiosity Higher Order Thinking Iec 60601 Injection Molding Medical Material Apply to this job.
Think you're the perfect candidate? Apply on company site Estimated Salary: $20 to $28 per hour based on qualifications.
).
This Medical Device Principal or Senior Systems Engineer will be part of the New Product Development/R&D team and will drive product innovation processes through the synthesis of unmet needs, product definition, and systems level design.
The Systems Engineer is expected to contribute to technical research, concept development, and design across healthcare/medical device programs that require great communication skills to collaborate across internal and external teams.
The Medical Device Systems Engineer will oversee all of the different components that contribute to the end user's experience of a medical device.
These might include software, hardware, usability, interface design, manufacturing, quality, etc.
The job requires someone that has the ability to identify gaps in technical knowledge required to develop a new medical device and create a plan to pursue the information.
This person must be a curious technical researcher that enjoys open-ended ambiguous challenges.
The Senior Systems Engineer will lead systems-oriented design (defining and designing product architectures, functions, and uses) and manage deliverables within the established criteria.
The System Engineer may act as the technical lead on system definition and technical research programs or will act as the systems lead on multidisciplinary programs.
Systems Engineers are responsible for creating documentation to drive technical research, capture product requirements, system design visualization, and prototype test results.
Responsibilities Contribute during all phases of the new medical device Product Development cycle with particular emphasis on product definition, conceptualization, and verification.
Lead technical research processes, collecting and documenting research findings and articulating insights and recommendations.
Facilitate the organization and distillment of evolving product requirements including the translation of user needs and the definition of technical requirements.
Communicate with client teams to gather inputs, and collaborate on product definition to maintain team alignment.
Lead system design and architecture definition conceptualization; creating block diagrams, use cases, feature functional mapping and modeling.
Support new concept generation and design engineering with reference requirements and targeted technical research activities.
Contribute to Design Verification and risk management activities.
REQUIREMENTS:
Must have had the actual title of Systems Engineer in the R&D new product development group working on new medical devices (IEC 60601).
A minimum of7 or more years of Medical Device experience is required.
Must have great interpersonal and communication skills with the ability to transmit technical concepts to non-technical teams and clients.
Bachelors' degree is required, Masters is GREATLY preferred (in Biomedical Engineering, Mechanical, EE, or similar).
Most of the other peers in this position have at least a Masters' degree.
Some have PhDs.
Depending on years of relevant experience, the company could hire someone at the Senior or Principal or even Senior Principal-level.
Must have the ability to identify gaps in technical knowledge (required to develop a new medical device) and create a plan to pursue the information.
This person must be a curious technical researcher that enjoys open-ended ambiguous challenges.
Must have strong experience using a Requirement Management Tool (ex.
JAMA, Helix, Doors, or related) steering the new product development cycle for a medical device.
Must be great at creating documentation to drive technical research, capture product requirements, system design visualization, and prototype test results.
Must be comfortable working in a project-based, consultative services, start-up-like environment driven by client demands which determine deadlines, and change priorities often.
You must be able to work on 2, 3, or more projects at the same time.
Comfortable translating unmet user needs and driving process of translating synthesized user needs into product requirements and system architectures.
Working knowledge of common technology systems and manufacturing processes, such as injection molding, sheet metal fabrication, machined part design, etc.
is nice to have.
Experience estimating the effort and duration of tasks, informing program milestones and expectations is nice to have.
Proven experience exploring and concepting technical systems, with an ability to visualize and prototype concepts for evaluation and refinement.
The ability to look at the big picture (30 thousand feet-level) of the project to help trade off requirements and implementation.
Must be willing to work onsite 3 days a week, every week.
NO Visa sponsorship.
Recommended Skills Architecture Curiosity Higher Order Thinking Iec 60601 Injection Molding Medical Material Apply to this job.
Think you're the perfect candidate? Apply on company site Estimated Salary: $20 to $28 per hour based on qualifications.
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