Apex Systems
Job#: 3017471
Job Description:
Apex Systems is a world class technology services business that incorporates industry or insights and experience to deliver solutions that fulfill our clients’ digital visions.
Apex has an opportunity for a Senior Systems Engineer. For applicants who are interested in this opportunity, send your updated resume to .
Here are the details:
Position:
Senior Systems Engineer
Location:
Onsite in Acton, MA or San Diego, CA
Project Duration: 6 months
Rate:
Negotiable Based on Experience
JOB DESCRIPTION Must be local to Acton, MA or San Diego, CA
The Senior Systems Engineer will be a technical lead in the design and development of our client’s innovation pipeline of wearable medical devices, including cloud and data management systems. This position entails leading systems engineering activities within existing and new product development projects. Education and work experience should encompass a vast array of engineering disciplines to include software, electrical, mechanical, and materials. Responsibilities: Serve as a key member of a cross-functional project team consisting of electrical, software, mechanical, manufacturing, and quality engineers to achieve project deliverables. Lead system definition tasks such as generating user needs, product requirements, and use-case descriptions. Contribute to system development by defining system and subsystem architectures. Identify and document system hazards, failure modes, and risk mitigations. Work with the technical centers of excellence domain subject matter experts and suppliers in the assessment, selection, integration, and qualification of key components and subsystems. Serve as technical consultant for integration, subsystem and system verification activities creating plans, protocols and reports, as necessary. Create and maintain traceability among design input, design output, design verification and validation, and risk management artifacts to ensure completeness and fully traceable design history file. Support the preparation of proposals, project plans and estimates, and present information and status to leadership and other stakeholders.
Serve as technical consultant for software development deliverables, such as design/architecture documents, requirements and failure mode analysis.
Participate in Agile ceremonies, such as Program Increment (PI) Planning, Retrospectives, Inspect and Adapt.
Provide guidance and support to junior engineers, promoting knowledge sharing and professional development.
Education and Experience: Minimum Requirements: Bachelor of Science in an Engineering (Systems, Biomedical, Electrical, Computer Science, Mechanical) discipline. A minimum of 3 to 7 years of experience working as a Systems Engineer or with systems engineering responsibilities in a multidisciplinary project team environment. 2 years of experience in leading a cross-functional development team. Demonstrated expertise in Systems Engineering practices such as requirements management, design trade-off and cost-benefit analysis, hazards and risk assessments. Experience with long term R&D development programs (concept/feasibility, development, commercialization).
Experience in application lifecycle management tools (i.e. Polarion ALM, Helix ALM, Doors).
Experience with root cause analysis and troubleshooting.
Experience writing verification plans, protocols and reports in a regulated industry. Experience with data analysis (Minitab, JMP, or MatLAB).
Proficient with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls). Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team, such as development, verification/validation, manufacturing, marketing, clinical, regulatory and quality experts.
Ability to communicate at multiple levels of an organization.
Ability to organize and judge priorities in a dynamic environment.
Preferred Skills and Competencies: Master of Science degree is desired; System Engineering training and/or certification is a plus.
Formal training in established Systems Engineering concepts.
1-2 years of experience in Model-based Systems Engineering.
1-2 years of experience working in Agile software development projects. Agile certification is a plus.
Experience with change orders within a Product Lifecycle Management (PLM) tool (Arena PLM).
Demonstrated skills in developing and introducing innovative FDA regulated medical devices in the drug delivery market.
Experience in reliability engineering practices such as reliability/data-based performance modeling, performance testing, prediction, HALT and HASS.
1-2 years of experience working with 3rd party partners/vendors.
Domain expertise in one or more of the following: security, cloud, communication (BLE, NFC), circuit design.
Six sigma training / certification.
2-3 years of experience in cloud technologies such as AWS and solid understanding of microservices, REST and HTTP.
General understanding of communication, mobile technology, IoT (Internet of Things), GDPR; a strong plus.
Experience with SolidWorks or Pro-Engineer.
Experience with software tools and coding (C , JAVA, Android UI).
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated’s Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click for more details.
Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6 months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide.
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Job Description:
Apex Systems is a world class technology services business that incorporates industry or insights and experience to deliver solutions that fulfill our clients’ digital visions.
Apex has an opportunity for a Senior Systems Engineer. For applicants who are interested in this opportunity, send your updated resume to .
Here are the details:
Position:
Senior Systems Engineer
Location:
Onsite in Acton, MA or San Diego, CA
Project Duration: 6 months
Rate:
Negotiable Based on Experience
JOB DESCRIPTION Must be local to Acton, MA or San Diego, CA
The Senior Systems Engineer will be a technical lead in the design and development of our client’s innovation pipeline of wearable medical devices, including cloud and data management systems. This position entails leading systems engineering activities within existing and new product development projects. Education and work experience should encompass a vast array of engineering disciplines to include software, electrical, mechanical, and materials. Responsibilities: Serve as a key member of a cross-functional project team consisting of electrical, software, mechanical, manufacturing, and quality engineers to achieve project deliverables. Lead system definition tasks such as generating user needs, product requirements, and use-case descriptions. Contribute to system development by defining system and subsystem architectures. Identify and document system hazards, failure modes, and risk mitigations. Work with the technical centers of excellence domain subject matter experts and suppliers in the assessment, selection, integration, and qualification of key components and subsystems. Serve as technical consultant for integration, subsystem and system verification activities creating plans, protocols and reports, as necessary. Create and maintain traceability among design input, design output, design verification and validation, and risk management artifacts to ensure completeness and fully traceable design history file. Support the preparation of proposals, project plans and estimates, and present information and status to leadership and other stakeholders.
Serve as technical consultant for software development deliverables, such as design/architecture documents, requirements and failure mode analysis.
Participate in Agile ceremonies, such as Program Increment (PI) Planning, Retrospectives, Inspect and Adapt.
Provide guidance and support to junior engineers, promoting knowledge sharing and professional development.
Education and Experience: Minimum Requirements: Bachelor of Science in an Engineering (Systems, Biomedical, Electrical, Computer Science, Mechanical) discipline. A minimum of 3 to 7 years of experience working as a Systems Engineer or with systems engineering responsibilities in a multidisciplinary project team environment. 2 years of experience in leading a cross-functional development team. Demonstrated expertise in Systems Engineering practices such as requirements management, design trade-off and cost-benefit analysis, hazards and risk assessments. Experience with long term R&D development programs (concept/feasibility, development, commercialization).
Experience in application lifecycle management tools (i.e. Polarion ALM, Helix ALM, Doors).
Experience with root cause analysis and troubleshooting.
Experience writing verification plans, protocols and reports in a regulated industry. Experience with data analysis (Minitab, JMP, or MatLAB).
Proficient with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls). Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team, such as development, verification/validation, manufacturing, marketing, clinical, regulatory and quality experts.
Ability to communicate at multiple levels of an organization.
Ability to organize and judge priorities in a dynamic environment.
Preferred Skills and Competencies: Master of Science degree is desired; System Engineering training and/or certification is a plus.
Formal training in established Systems Engineering concepts.
1-2 years of experience in Model-based Systems Engineering.
1-2 years of experience working in Agile software development projects. Agile certification is a plus.
Experience with change orders within a Product Lifecycle Management (PLM) tool (Arena PLM).
Demonstrated skills in developing and introducing innovative FDA regulated medical devices in the drug delivery market.
Experience in reliability engineering practices such as reliability/data-based performance modeling, performance testing, prediction, HALT and HASS.
1-2 years of experience working with 3rd party partners/vendors.
Domain expertise in one or more of the following: security, cloud, communication (BLE, NFC), circuit design.
Six sigma training / certification.
2-3 years of experience in cloud technologies such as AWS and solid understanding of microservices, REST and HTTP.
General understanding of communication, mobile technology, IoT (Internet of Things), GDPR; a strong plus.
Experience with SolidWorks or Pro-Engineer.
Experience with software tools and coding (C , JAVA, Android UI).
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated’s Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click for more details.
Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6 months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide.
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