Entegee R&D Engineer - 53622773 - JA in Boulder, Colorado

R&D Engineer - 53622773 - JA

Job Code: 53622773Job Location: Boulder, COCategory: Manufacturing EngineerLast Updated: 10/11/2016Apply Now!

Job Description:

The R&D Engineer is a contributor in systems design for safety, reliability, and quality to leverage their experience and expertise in systems software, computer architecture, electromechanical design and regulatory compliance to provide timely and actionable information on design to cross functional product support teams. Responsible for supporting project teams of engineers from multiple disciplines who are working on the support of commercialized systems.

• 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 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 lead, coordinate, 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

• Experience with systems engineering principles, including requirement analysis and allocation, architecture, verification, and validation; INCOSE CSEP a plus

• Experience with system architecture, analysis, and design, including design partitioning, interface specification, and requirement allocation

• Reviews and approves product documentation, drawings, process and design verification/validation

• Produce technical reports to support product changes or quality assurance investigations

• 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


• Bachelor’s degree (minimum) in Engineering or Scientific discipline

• 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


• Advanced degree in Engineering or Scientific discipline

• Provide leadership and execution as needed for maintenance of requirements management systems, tools, processes and best practices

• Strong analytical and problem solving skills

• 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 functional analysis, timeline analysis, and interface definition

• Excellent written and communication skills

• Experience working on multiple projects in a deadline driven environment

• Successful experience thriving in a cross functional or matrix team environment

• Support or lead cross functional teams, both internal and external, and directly contribute to their success by accomplishing short or long-term objectives

For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or engineeringteam@entegee.com.

Please reference job # 53622773JA

Equal Opportunity Employer