Principal Systems Engineer Job at Columbia Technology Partners (Annapolis Junction)

New

Principal Systems Engineer

As a Principal Systems Engineer at Baxter, you will play a critical role in both...

Location

United States , Skaneateles Falls

Salary:

112000.00 - 154000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in Mechanical, Electrical, Software Engineering, or a related technical discipline
5+ years of relevant engineering experience, preferably in medical devices or a regulated industry
Strong working knowledge of ISO 14971
Strong working knowledge of IEC 62304
Strong working knowledge of IEC/TR 80002-1
Demonstrated ability to lead through influence in a cross-functional team environment
Strong interpersonal and communication skills
Ability to make sound decisions in the absence of complete information and navigate ambiguity effectively
Strategic mindset with strong attention to detail and execution discipline
Proven ability to manage multiple priorities and deliverables in parallel

Job Responsibility

Translate customer needs, business objectives, and regulatory requirements into clear, testable system-level requirements
Lead and execute risk management activities in accordance with ISO 14971
Decompose system-level requirements into subsystem and module-level requirements, ensuring traceability
Plan and oversee reliability and robustness activities to ensure product performance over time
Lead cross-functional teams in identifying and mitigating technical risks, resolving issues, and managing test defects
Evaluate product and design changes holistically to ensure impacts are fully assessed across system, regulatory, and business dimensions
Drive alignment across engineering, quality, and regulatory functions on system-level decisions and deliverables
Support adherence to Baxter product development processes, documentation expectations, and regulatory requirements

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

New

Principal Systems Engineer

This is where new knowledge is discovered. Baxter's Research and Development tea...

Location

United States , Skaneateles Falls

Salary:

112000.00 - 154000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in Mechanical, Electrical, Software Engineering, or a related technical discipline
5+ years of relevant engineering experience, preferably in medical devices or a regulated industry
Strong working knowledge of: ISO 14971 (Application of Risk Management to Medical Devices)
IEC 62304 (Medical Device Software Lifecycle Processes)
IEC/TR 80002-1 (Guidance on Software Risk Management)
Demonstrated ability to lead through influence in a cross-functional team environment
Strong interpersonal and communication skills, with the ability to clearly convey complex technical concepts
Ability to make sound decisions in the absence of complete information and navigate ambiguity effectively
Strategic mindset with strong attention to detail and execution discipline
Proven ability to manage multiple priorities and deliverables in parallel

Job Responsibility

Translate customer needs, business objectives, and regulatory requirements into clear, testable system-level requirements
Lead and execute risk management activities in accordance with ISO 14971 (Medical Device Risk Management Standard), including: Risk management planning, Risk analysis and evaluation, Risk control implementation and verification
Decompose system-level requirements into subsystem and module-level requirements, ensuring traceability
Plan and oversee reliability and robustness activities to ensure product performance over time
Lead cross-functional teams in identifying and mitigating technical risks, resolving issues, and managing test defects
Evaluate product and design changes holistically to ensure impacts are fully assessed across system, regulatory, and business dimensions
Drive alignment across engineering, quality, and regulatory functions on system-level decisions and deliverables
Support adherence to Baxter product development processes, documentation expectations, and regulatory requirements

What we offer

medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
educational assistance programs
paid holidays
paid time off ranging from 20 to 35 days based on length of service
family and medical leaves of absence
paid parental leave

Fulltime

Principal Systems Engineer

As a Principal Systems Engineer at Baxter, you will play a key role in the susta...

Location

United States , Skaneateles Falls

Salary:

112000.00 - 154000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s Degree (Mechanical, Electrical, Software Engineering or comparable technical discipline)
5+ years of engineering experience
Knowledge in ISO 14971 Application of Risk Management to Medical Devices
Knowledge in IEC 62304 and IEC/TR 80002-1
Strong interpersonal skills with the ability to collaboratively with others in a team environment
Able to work in the absence of complete information and make timely decisions
Excellent verbal and written communication
Strategic thinker but can execute with great attention to detail
Organized and able to progress on many different tasks in parallel
Proficient problem-solving skills

Job Responsibility

Translate customer needs, business constraints, and regulatory requirements into product functional and performance system requirements
Conduct risk management activities including planning, risk analysis, risk evaluation and control
Decompose and allocate system level requirements into module level requirements
Plan and oversee reliability and robustness activities
Lead the technical team through technical risk identification and management as well as issue and test defect resolution
Ensure changes are analyzed holistically and impacts are fully understood

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Fulltime

Principal Systems Engineer

Columbia Technology Partners is hiring a Principal Systems Engineer to lead the ...

Location

United States , Annapolis Junction

Salary:

190000.00 - 225000.00 USD / Year

Columbia Technology Partners

Expiration Date

Until further notice

Requirements

U.S. Citizenship is required for all applicants
Employment is contingent upon successful completion of a security background investigation and polygraph
DOD 8570 Certification
This position requires an active Security Clearance with appropriate Polygraph
Bachelor's degree in an accredited engineering or related technical discipline with twenty (20) years of systems engineering experience
or High School Diploma or GED with twenty-five (25) years of broad systems engineering experience across relevant disciplines
Proven experience supporting FORNSAT systems and executing complex systems integration efforts

Job Responsibility

Serve as a senior technical lead for the engineering, integration, validation, and operational sustainment of RF-enabled and FORNSAT hardware and software systems
Design and implement enterprise system architectures built on Government Off-The-Shelf (GOTS) technologies
Engineer, deploy, and maintain virtualization platforms supporting both cloud-hosted and on-premises environments
Perform advanced administration and troubleshooting of Linux systems to ensure system resilience, uptime, and security compliance
Integrate, configure, and support GOTS solutions within large-scale, interconnected system environments
Lead Windows Server operations, including system optimization, automation, security hardening, and lifecycle management
Coordinate with engineering, operations, and mission partners to ensure system interoperability and operational readiness
Establish and maintain technical standards, system documentation, monitoring strategies, and cybersecurity best practices

What we offer

Medical insurance
Vision insurance
Dental insurance
401k with 6% company contribution
Paid Time Off
Customizable leave plans
Jury Duty Leave
Bereavement Leave
Military Leave
Up to $10,000 for approved career-related learning, training, education, and/or tuition

Fulltime

Principal Systems Engineer

This is where your work saves lives. The research we do and the products we dev...

Location

United States , Round Lake

Salary:

112000.00 - 154000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree required with 5+ years of experience or Masters with 3+ years of experience.
Solid understanding of systems engineering principals and related disciplines, Electro/Mechanical, Digital Interface, Fluid Mechanics, Materials Science, etc.
Success in delivering results on technical challenges including investigative and problem-solving skills (DFSS/DMAIC/CAPA).
Prior medical device preferred, Infusion Pumps and Syringe Pumps is a plus.
Good communication skills, both oral and written.

Job Responsibility

Lead development of Design Inputs and Digital Interface Requirements.
Work with cross functional team members (e.g., Marketing and Clinical personnel) to translate user needs into system requirements.
Lead engineering resources (Electrical, Mechanical, and Software) in the decomposition of system requirements to derived requirements.
Contributes to resolution of competing constraints among inter-related functions (e.g., engineering, manufacturing, regulatory, marketing) required to deliver products to market.
Resolves interface issues and have the ability to document theory of operations of complex medical product designs.
Work with verification engineers to define test strategies for the development of verification plans and validation plans using requirement tracing methods.
Support risk analysis activities from the capture of inherent hazards through mitigation, including quantitative residual risk calculation in support of the Safety Assurance Case.
Implement configuration management through the complete product life cycle, including design, development, and sustaining phases.
Interface with Manufacturing, Service, Product Surveillance, Supply Chain, and Customer Training staff through the design transfer process.
Ensure compliance to the product development process and Quality System.

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Principal Systems Engineer

This is where your work saves lives. As a Principal Systems Engineer at Baxter, ...

Location

United States , Skaneateles Falls

Salary:

112000.00 - 154000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's Degree (Mechanical, Electrical, Software Engineering or comparable technical discipline)
5+ years of engineering experience
Knowledge in ISO 14971 Application of Risk Management to Medical Devices
Knowledge in IEC 62304 and IEC/TR 80002-1
Strong interpersonal skills with the ability to collaboratively with others in a team environment
Able to work in the absence of complete information and make timely decisions
Excellent verbal and written communication
Strategic thinker but can execute with great attention to detail
Organized and able to progress on many different tasks in parallel
Proficient problem-solving skills

Job Responsibility

Translate customer needs, business constraints, and regulatory requirements into product functional and performance system requirements
Conduct risk management activities including planning, risk analysis, risk evaluation and control
Decompose and allocate system level requirements into module level requirements
Plan and oversee reliability and robustness activities
Lead the technical team through technical risk identification and management as well as issue and test defect resolution
Ensure changes are analyzed holistically and impacts are fully understood.

What we offer

Support for Parents
Continuing Education/Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Principal Systems Engineer

This is where your work saves lives. The research we do and the products we deve...

Location

United States , Round Lake

Salary:

112000.00 - 154000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree required with 5+ years of experience or Masters with 3+ years of experience
Solid understanding of systems engineering principals and related disciplines, Electro/Mechanical, Digital Interface, Fluid Mechanics, Materials Science, etc
Success in delivering results on technical challenges including investigative and problem-solving skills (DFSS/DMAIC/CAPA)
Prior medical device preferred, Infusion Pumps and Syringe Pumps is a plus
Good communication skills, both oral and written
Applicants must be authorized to work for any employer in the U.S.
No sponsorship available

Job Responsibility

Lead development of Design Inputs and Digital Interface Requirements
Work with cross functional team members to translate user needs into system requirements
Lead engineering resources in decomposition of system requirements to derived requirements
Contributes to resolution of competing constraints among inter-related functions
Resolves interface issues and document theory of operations of complex medical product designs
Work with verification engineers to define test strategies for verification and validation plans
Support risk analysis activities from hazard capture through mitigation, including quantitative residual risk calculation
Implement configuration management through complete product life cycle
Interface with Manufacturing, Service, Product Surveillance, Supply Chain, and Customer Training staff
Ensure compliance to product development process and Quality System

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Principal Systems Engineer

This is where your work saves lives. As a Principal Systems Engineer at Baxter, ...

Location

United States , Skaneateles Falls

Salary:

112000.00 - 154000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's Degree (Mechanical, Electrical, Software Engineering or comparable technical discipline)
5+ years of engineering experience
Knowledge in ISO 14971 Application of Risk Management to Medical Devices
Knowledge in IEC 62304 and IEC/TR 80002-1
Strong interpersonal skills with the ability to collaboratively with others in a team environment
Able to work in the absence of complete information and make timely decisions
Excellent verbal and written communication
Strategic thinker but can execute with great attention to detail
Organized and able to progress on many different tasks in parallel
Proficient problem-solving skills

Job Responsibility

Translate customer needs, business constraints, and regulatory requirements into product functional and performance system requirements
Conduct risk management activities including planning, risk analysis, risk evaluation and control
Decompose and allocate system level requirements into module level requirements
Plan and oversee reliability and robustness activities
Lead the technical team through technical risk identification and management as well as issue and test defect resolution
Ensure changes are analyzed holistically and impacts are fully understood

What we offer

Medical and dental coverage starting on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP) with ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP) with employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Fulltime

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