Systems Engineer
Position
Summary:
The Systems Engineer is an Exempt/Full-Time position that works alongside the development team to ensure product specifications are achieved and in compliance with medical regulatory practices and company procedures.
The role assists in system risk analysis, as well as identification, prioritization, and documentation of customer needs and requirements.
The Systems Engineer develops system and sub-system interface requirements that assure the completed system meets required functionality.
Together with the development team, the Systems Engineer is responsible for investigation, evaluation, and selection of the best system structure and documentation.
Responsibilities/Duties:
oResponsible for overall system engineering / testing for a complex electromagnetic surgical navigation product platform.
oDevelops/maintains system architecture and interface requirements for the products, based on technology and platform strategies.
oDefines subassembly interfaces and subassembly requirements to both internal and outsourced design teams.
oImplements and tests the product platform to ensure high quality, robust behavior and safety in accordance with medical device regulatory standards and customer requirements.
oResponsible for daily system engineering activities including leading issue resolution and communication across teams in order to deliver results on-time and on-budget.
oDevelops/maintains the risk management file in accordance with ISO 14971 and ensures product safety in accordance with IEC 60601-1 and its appropriate subparts.
oWorks with other team members and functions to execute design reviews of complex Medical Devices.
oDrives structural design documentation and plans by applying engineering best practices.
oConducts impact analysis for design changes and implements necessary actions including estimates of impact to time, budget, and scope.
oEffectively coordinates test activities throughout the project to drive efficiency in V&V in collaboration with the regulatory resource to ensure a complete and effective 510(k) submission.
oUnderstands and follows quality and product development processes.
oIncorporates business, market, industry, and competitive knowledge into technical solutions.
oDetermines required tasks and completes on time with minimal supervision.
oIdentifies and communicates potential risks with appropriate mitigations.
oSynthesizes complex information gathered from a variety of sources and disseminates to others.
oAdditional duties as assigned.
Minimum Qualifications, Education, and Experience Required Education and
Experience:
oBachelor's degree with 3
years of medical device development experience is highly desirable oInvolvement with medical device regulatory standards such as IEC 60601, IEC 62304, ISO 14971 and ISO 13485 including experience with system risk/hazard analysis oExperience with FDA 510(k) product/testing requirements oExcellent IT/computer skills and a willingness to learn new tools as they become relevant oFlexibility and ability to self-start on new challenges, problem-solving with minimal supervision oAbility to work efficiently on multiple tasks with deadlines oAbility to work in a diverse team with members of varying education and experience levels oCreative/innovative, able to rapidly problem-solve and work well given typical project schedules oSuperb organizational and multitasking skills as well as strong written and verbal communication skills oFamiliarity with ISO and IEC standards pertaining to medical devices Abilities:
oProficiency with functional analysis and cascading down from user level to subsystem/ component level of customer requirements oExperience working in Quality or Regulatory capacities in the medical device industry oSkilled in developing test plans and validation protocols in a regulated environment oCapability of using automated software testing tools oFamiliarity with numerical analysis and methods oAbility to work effectively in a multidisciplinary team while maintaining independence from technical development oStrong analytical skills and willingness to develop understanding of relevant concepts in medicine and mechanical, electrical, and materials engineering oDemonstrable experience in performing risk assessment, software validation and testing Centerline Biomedical is an equal opportunity employer and strongly supports diversity in the workplace.
We believe that diverse ideas, opinions, and perspectives will build a strong foundation for success.
In order to provide equal employment and advancement opportunities to all individuals, employment decisions at Centerline Biomedical will be based on merit, qualifications, and abilities.
Centerline Biomedical does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, or any other characteristic protected by law.
Recommended Skills Analytical Communication Creativity Curiosity Customer Demand Planning Engineering Estimated Salary: $20 to $28 per hour based on qualifications.
Summary:
The Systems Engineer is an Exempt/Full-Time position that works alongside the development team to ensure product specifications are achieved and in compliance with medical regulatory practices and company procedures.
The role assists in system risk analysis, as well as identification, prioritization, and documentation of customer needs and requirements.
The Systems Engineer develops system and sub-system interface requirements that assure the completed system meets required functionality.
Together with the development team, the Systems Engineer is responsible for investigation, evaluation, and selection of the best system structure and documentation.
Responsibilities/Duties:
oResponsible for overall system engineering / testing for a complex electromagnetic surgical navigation product platform.
oDevelops/maintains system architecture and interface requirements for the products, based on technology and platform strategies.
oDefines subassembly interfaces and subassembly requirements to both internal and outsourced design teams.
oImplements and tests the product platform to ensure high quality, robust behavior and safety in accordance with medical device regulatory standards and customer requirements.
oResponsible for daily system engineering activities including leading issue resolution and communication across teams in order to deliver results on-time and on-budget.
oDevelops/maintains the risk management file in accordance with ISO 14971 and ensures product safety in accordance with IEC 60601-1 and its appropriate subparts.
oWorks with other team members and functions to execute design reviews of complex Medical Devices.
oDrives structural design documentation and plans by applying engineering best practices.
oConducts impact analysis for design changes and implements necessary actions including estimates of impact to time, budget, and scope.
oEffectively coordinates test activities throughout the project to drive efficiency in V&V in collaboration with the regulatory resource to ensure a complete and effective 510(k) submission.
oUnderstands and follows quality and product development processes.
oIncorporates business, market, industry, and competitive knowledge into technical solutions.
oDetermines required tasks and completes on time with minimal supervision.
oIdentifies and communicates potential risks with appropriate mitigations.
oSynthesizes complex information gathered from a variety of sources and disseminates to others.
oAdditional duties as assigned.
Minimum Qualifications, Education, and Experience Required Education and
Experience:
oBachelor's degree with 3
years of medical device development experience is highly desirable oInvolvement with medical device regulatory standards such as IEC 60601, IEC 62304, ISO 14971 and ISO 13485 including experience with system risk/hazard analysis oExperience with FDA 510(k) product/testing requirements oExcellent IT/computer skills and a willingness to learn new tools as they become relevant oFlexibility and ability to self-start on new challenges, problem-solving with minimal supervision oAbility to work efficiently on multiple tasks with deadlines oAbility to work in a diverse team with members of varying education and experience levels oCreative/innovative, able to rapidly problem-solve and work well given typical project schedules oSuperb organizational and multitasking skills as well as strong written and verbal communication skills oFamiliarity with ISO and IEC standards pertaining to medical devices Abilities:
oProficiency with functional analysis and cascading down from user level to subsystem/ component level of customer requirements oExperience working in Quality or Regulatory capacities in the medical device industry oSkilled in developing test plans and validation protocols in a regulated environment oCapability of using automated software testing tools oFamiliarity with numerical analysis and methods oAbility to work effectively in a multidisciplinary team while maintaining independence from technical development oStrong analytical skills and willingness to develop understanding of relevant concepts in medicine and mechanical, electrical, and materials engineering oDemonstrable experience in performing risk assessment, software validation and testing Centerline Biomedical is an equal opportunity employer and strongly supports diversity in the workplace.
We believe that diverse ideas, opinions, and perspectives will build a strong foundation for success.
In order to provide equal employment and advancement opportunities to all individuals, employment decisions at Centerline Biomedical will be based on merit, qualifications, and abilities.
Centerline Biomedical does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, or any other characteristic protected by law.
Recommended Skills Analytical Communication Creativity Curiosity Customer Demand Planning Engineering Estimated Salary: $20 to $28 per hour based on qualifications.
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