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SR. SYSTEMS ENGINEER ( Please share resume at mohammed@urbanesystems.com )

In Washington / United States

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SR. SYSTEMS ENGINEER ( Please share resume at mohammed@urbanesystems.com )   

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JOB TITLE:

SR. SYSTEMS ENGINEER ( Please share resume at mohammed@urbanesystems.com )

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Snoqualmie Washington / United States

JOB DESCRIPTION:

Responsibilities:

  • Work with the various engineering disciplines to translate market-driven needs into product requirements and ultimately flow them down into lower level hardware and firmware requirements or technical specification documents.
  • Lead the requirements development, systems level architecture design and external communications/connectivity interface designs by collaborating with cross-functional disciplines within and outside R&D.
  • Work with program core team members including Quality and Regulatory to ensure conformance to established design development processes and procedures.
  • Responsible for ensuring 100% requirement to V&V test plan coverage on programs.
  • Lead FMEA discussions at all levels to ensure product quality and reliability.
  • Function well in a team environment. Gains consensus, leads, influences and ensures cross-discipline participation and feedback.
  • Demonstrate good design practices and methodologies.
  • Uphold the Company's core values of Integrity, Innovation, Accountability, and Teamwork.
  • Demonstrate behavior consistent with the Company's Code of Ethics and Conduct. Ensure that team members (direct or indirect reports) are trained and evaluated on their knowledge and adherence to the Company's values, Code of Ethics and Conduct, and applicable compliance policies.
  • It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
  • Duties may be modified or assigned at any time to meet the needs of the business.

    Qualifications:
DESIRED REQUIREMENTS:
  • Bachelor of Science degree in Electrical, Mechanical, Biomedical, Computer Engineering, Computer Science, or similar related degree. Master's degree is desirable.
  • 8+ years' relevant systems engineering and/or cybersecurity engineering experience, of which as minimum of 3 years in the medical device industry.
  • Experience with systems engineering processes, in particular establishing design inputs and top down design using system requirements methodologies.
  • Must have familiarity with security standards and frameworks including NIST 800-53, NIST CSF, NIST 800-171, IEC 80001, and/or ISO 27001/5, and/or US government ATO processes.
  • Experience performing Threat, Exploit, and Vulnerability analysis of products and systems. Familiarity performing and reporting vulnerability testing of software and systems.
  • Familiar with one or more risk management techniques (i.e. Hazard Analysis, Risk Analysis, Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), etc.).
  • Familiarity with and working knowledge of automated requirements traceability tools, such as Rational RequisitePro, IBM Doors, Rational Quality Manager, etc.
  • Experience in an Agile Software Development Environment will be a plus.
  • Candidate should be knowledgeable and have experience in hardware and firmware development and the processes associated with product life cycles, such as stage/phase gate product development processes.
  • Able to work, influence and lead in a highly cross-functional team environment.
  • Familiarity with FDA Quality Systems Regulations (QSR) preferred.
  • Excellent communication and negotiation skills, for both internal and external audiences, at all levels.
  • Knowledge of and ability to work within a global corporate environment is required.
  • Must travel internationally and be able to acquire all necessary travel documents. Travel up to 10%.

Program managers report to him worldwide, as well as systems engineering

Owns the product requirements document

o Significant doc that contains agreement between marketing and engineering about what the customer/field needs

o All things traced out in design trace matrix, verification protocols, own all traceability

o Digested down to the development stack, development V***

o Need to understand product intimately--self starter, leader, answer questions about what the product does

o Come from med device/regulated (air/rail/etc.)

o Mixed discipline products--Philips, GE, Abbott Labs

Product

o Reinventing the entire product line; patient monitoring (bedside monitor), feeds data to surveillance (up to 16 patients on the screen, war room monitoring); enterprise back office software (pure software)

o Heavy weight to software vs hardware/firmware

Skills

o Not looking for a singular focus/exclusive focus on systems design--want to ensure systems engineering and integration

o PRD side--product requirements document

o Software and hardware requirements

o Traceability ownership across testing

o Recognize that when you have a conflict between 2 SMEs, that's not a bad thing--that means there's hidden information

o Verification and Validation testing/standards/FDA regulations

o Standards (NIST/606-01/1335/etc.)

o Doors and Azure DevOps (could be comparable cloud experience, trace requirements into Azure DevOps)

Position Details

POSTED:

Jul 08, 2021

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16204869270479234

LOCATION:

Washington / United States

CITY:

Snoqualmie

Job Origin:

CEIPAL_ORGANIC_FEED

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

SR. SYSTEMS ENGINEER ( Please share resume at mohammed@urbanesystems.com )    Apply

Click on the below icons to share this job to Linkedin, Twitter!

Responsibilities:

  • Work with the various engineering disciplines to translate market-driven needs into product requirements and ultimately flow them down into lower level hardware and firmware requirements or technical specification documents.
  • Lead the requirements development, systems level architecture design and external communications/connectivity interface designs by collaborating with cross-functional disciplines within and outside R&D.
  • Work with program core team members including Quality and Regulatory to ensure conformance to established design development processes and procedures.
  • Responsible for ensuring 100% requirement to V&V test plan coverage on programs.
  • Lead FMEA discussions at all levels to ensure product quality and reliability.
  • Function well in a team environment. Gains consensus, leads, influences and ensures cross-discipline participation and feedback.
  • Demonstrate good design practices and methodologies.
  • Uphold the Company's core values of Integrity, Innovation, Accountability, and Teamwork.
  • Demonstrate behavior consistent with the Company's Code of Ethics and Conduct. Ensure that team members (direct or indirect reports) are trained and evaluated on their knowledge and adherence to the Company's values, Code of Ethics and Conduct, and applicable compliance policies.
  • It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
  • Duties may be modified or assigned at any time to meet the needs of the business.

    Qualifications:
DESIRED REQUIREMENTS:
  • Bachelor of Science degree in Electrical, Mechanical, Biomedical, Computer Engineering, Computer Science, or similar related degree. Master's degree is desirable.
  • 8+ years' relevant systems engineering and/or cybersecurity engineering experience, of which as minimum of 3 years in the medical device industry.
  • Experience with systems engineering processes, in particular establishing design inputs and top down design using system requirements methodologies.
  • Must have familiarity with security standards and frameworks including NIST 800-53, NIST CSF, NIST 800-171, IEC 80001, and/or ISO 27001/5, and/or US government ATO processes.
  • Experience performing Threat, Exploit, and Vulnerability analysis of products and systems. Familiarity performing and reporting vulnerability testing of software and systems.
  • Familiar with one or more risk management techniques (i.e. Hazard Analysis, Risk Analysis, Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), etc.).
  • Familiarity with and working knowledge of automated requirements traceability tools, such as Rational RequisitePro, IBM Doors, Rational Quality Manager, etc.
  • Experience in an Agile Software Development Environment will be a plus.
  • Candidate should be knowledgeable and have experience in hardware and firmware development and the processes associated with product life cycles, such as stage/phase gate product development processes.
  • Able to work, influence and lead in a highly cross-functional team environment.
  • Familiarity with FDA Quality Systems Regulations (QSR) preferred.
  • Excellent communication and negotiation skills, for both internal and external audiences, at all levels.
  • Knowledge of and ability to work within a global corporate environment is required.
  • Must travel internationally and be able to acquire all necessary travel documents. Travel up to 10%.

Program managers report to him worldwide, as well as systems engineering

Owns the product requirements document

o Significant doc that contains agreement between marketing and engineering about what the customer/field needs

o All things traced out in design trace matrix, verification protocols, own all traceability

o Digested down to the development stack, development V***

o Need to understand product intimately--self starter, leader, answer questions about what the product does

o Come from med device/regulated (air/rail/etc.)

o Mixed discipline products--Philips, GE, Abbott Labs

Product

o Reinventing the entire product line; patient monitoring (bedside monitor), feeds data to surveillance (up to 16 patients on the screen, war room monitoring); enterprise back office software (pure software)

o Heavy weight to software vs hardware/firmware

Skills

o Not looking for a singular focus/exclusive focus on systems design--want to ensure systems engineering and integration

o PRD side--product requirements document

o Software and hardware requirements

o Traceability ownership across testing

o Recognize that when you have a conflict between 2 SMEs, that's not a bad thing--that means there's hidden information

o Verification and Validation testing/standards/FDA regulations

o Standards (NIST/606-01/1335/etc.)

o Doors and Azure DevOps (could be comparable cloud experience, trace requirements into Azure DevOps)


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