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Systems Engineer
Ref No.: 18-25261
Location: Boulder, Colorado
Bachelor’s degree (minimum) in Engineering or Scientific discipline
Years’ Experience Required. 2+ years of technical engineering experience
Top required skills:
1) Experience generating technical documentation such as product
requirements, specifications, engineering reports, test plans &
procedures, validation plans, or validation reports.
2) A proven track record of applying systems engineering principles and
tools in the design, development, and evaluation of hardware and
software products brought to market
3) Detail-oriented with strong commitment to quality

** no vendor call

Responsibilities Include:

*Responsible for assuring projects meet regulatory requirements including FDA Quality System Regulations 21CFR Part 820, Medical Device Directive (MDD) 93/42/EEC, Canada Medical Devices Regulations (CMDR) (SOR/98-282) and internal Healthcare procedures.

*Applies knowledge of IEC 60601-1 Medical Electrical Equipment and collateral standards, IEC 62366 Usability, and IEC 62304 Software Lifecycle to sustaining engineering projects.

*Serves as a design representative on one or more project teams engaged
in sustaining engineering projects to execute, trace, verify and document system analysis and design activities, including but not limited to, security, privacy, environmental, health, safety, reliability, risk, usability and interface management

*Applies systems engineering principles in the design and maintenance of Medical Device Hardware & Software projects, including requirement analysis and allocation, architecture, verification, and validation.

*Reviews product documentation, drawings, process and design verification/validation for fellow engineers on project teams.

*Interfacing with all project team members including engineering (mechanical, electrical, software, systems, and test), quality, regulatory, marketing, technical communications, end users, technical support, production and suppliers.

Must Have: Minimum Qualifications

*Bachelor’s degree (minimum) in Engineering or Scientific discipline and 2+ years of technical engineering experience or advanced degree in Engineering or Scientific discipline with 0+ years of technical engineering experience.

*Experience generating technical documentation such as product requirements, specifications, engineering reports, test plans & procedures, validation plans, or validation reports.

*Experience in product development in a regulated industry such as medical device, defense, aerospace or automotive.

*A proven track record of applying systems engineering principles and tools in the design, development, and evaluation of hardware and software products brought to market.

*Detail-oriented with strong commitment to quality and to the workplace.

*Ability to work with multi-functional development teams

*Detail-oriented with strong commitment to quality and to the workplace.

Nice to Have:

*Experience with Requirements Management Software such as Polarion or DOORS.

*Experience in maintenance and deployment of requirements management systems (such as Polarion or DOORS).

*Experience in the medical device industry.