Primary Talent Partners
Neuromodulation Systems Engineer
Primary Talent Partners, Minneapolis, Minnesota, United States, 55400
Overview
Primary Talent Partners has a 12 month contract opening for a Neuromodulation Systems Engineer to join a multinational medical device company for an onsite position operating out of Minneapolis, MN. Pay:
$50.00/hr – $60.00/hr based on experience and academia Contract:
12 months, extensions likely, conversion possible Type:
W-2, cannot support C2C or provide visa sponsorship Summary
In this role as a Sr. Systems Engineer, you will have responsibility for contributing to the development of Neuromodulation 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 within the Neuromodulation Operating Unit. Neuromodulation products provide therapy for a variety of conditions including Chronic Pain, Cancer Pain, Severe Spasticity, Epilepsy, Dystonia, Essential Tremor, and Parkinson’s Disease. Products include implantable and external neurostimulators, implantable infusion pumps, and associated device recharge and programming instruments. 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
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. Qualifications
Bachelor’s degree is required. 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 Responsibilities may include the following and other duties may be assigned: Performs technical planning, system integration, verification and validation, evaluates alternatives including cost and risk, supportability and analyses for total systems. Analyses are performed at all levels of total system product to include: concept, design, fabrication, test, installation, operation, maintenance and disposal. Ensures the logical and systematic conversion of product requirements into total systems solutions 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. Specialist Career Stream: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). Differentiating Factors Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others’ work product. Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience. Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws. If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
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Primary Talent Partners has a 12 month contract opening for a Neuromodulation Systems Engineer to join a multinational medical device company for an onsite position operating out of Minneapolis, MN. Pay:
$50.00/hr – $60.00/hr based on experience and academia Contract:
12 months, extensions likely, conversion possible Type:
W-2, cannot support C2C or provide visa sponsorship Summary
In this role as a Sr. Systems Engineer, you will have responsibility for contributing to the development of Neuromodulation 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 within the Neuromodulation Operating Unit. Neuromodulation products provide therapy for a variety of conditions including Chronic Pain, Cancer Pain, Severe Spasticity, Epilepsy, Dystonia, Essential Tremor, and Parkinson’s Disease. Products include implantable and external neurostimulators, implantable infusion pumps, and associated device recharge and programming instruments. 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
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. Qualifications
Bachelor’s degree is required. 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 Responsibilities may include the following and other duties may be assigned: Performs technical planning, system integration, verification and validation, evaluates alternatives including cost and risk, supportability and analyses for total systems. Analyses are performed at all levels of total system product to include: concept, design, fabrication, test, installation, operation, maintenance and disposal. Ensures the logical and systematic conversion of product requirements into total systems solutions 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. Specialist Career Stream: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). Differentiating Factors Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others’ work product. Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience. Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws. If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
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