Systems Engineer
Diabetes Youth Families
full-time
Posted on:
Location Type: Hybrid
Location: Acton • California, Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $79,650 - $119,475 per year
Job Level
Mid-LevelSenior
About the role
- Lead system definition tasks such as generating user needs, product requirements, and use-case descriptions.
- Contribute to system development by defining system, subsystem architecture and design for manufacturing.
- 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 a technical consulting resource for integration, subsystem and system verification activities creating plans, protocols and reports as necessary.
- Oversee engineering evaluations & data analysis reviews.
- Create and maintain traceability among design input, design output, verification and validation, and risk management artifacts of the design in compliance with FDA guidelines.
- Support the preparation of proposals, program plans, estimates, and present information and status to leadership and other stakeholders.
- Drive product investigations, using statistical analysis methodologies.
- Contribute to team goals by accomplishing related tasks as required.
Requirements
- Bachelor's Degree required (preferred field of study in Engineering including Biomedical, Electrical, Software, Mechanical)
- A minimum of three (3) years’ experience (inclusive of any post-grad work) working on technical design or Systems Engineering in a multidisciplinary project team environment.
- 2+ years of experience in working on technical design.
- Domain expertise in one of more associated domains; preferably Electrical or Mechanical Engineering, with exposure to Software, Quality, and Test Engineering.
- Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team that includes 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.
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
system definitionsystem architecturedesign for manufacturingrisk mitigationstatistical analysisverification and validationtraceabilitytechnical designdata analysis
Soft skills
project team skillscollaborationcommunicationorganizational skillsprioritization