Embedded Software Systems Engineer
Diabetes Youth Families
full-time
Posted on:
Location Type: Hybrid
Location: Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $102,825 - $154,238 per year
Job Level
Mid-LevelSenior
About the role
- Work with Software Engineers to drive the generation of Software Functional Requirements that meet higher level Product Requirements and product backlog goals
- Lead cross-functional reviews and approval of Software Functional Requirements
- Document system hazards, failure modes, and risk mitigations with the Software Engineering team
- Create and maintain traceability among design input, design output, verification and validation, and risk management artifacts in compliance with FDA guidelines
- Collaborate closely with Product Owner, Software Engineering, Software QA and other cross-functional teams to ensure timely deliverables for Agile team execution
- Drive defect triaging and other activities as needed
- Drive generation of appropriate deliverables in accordance with FDA and corporate SOPs
- Contribute to team goals by accomplishing related tasks as required
Requirements
- BS in an Engineering (Biomedical, Electrical, Software) discipline preferred
- 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 or more associated domains; preferably Software or Electrical Engineering
- Demonstrated understanding of Systems Engineering practices such as requirements management and risk analyses
- Experience and capability working collaboratively under a Quality Management System (QMS)
- Experience working with cross-functional teams including 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
- Preferred: Experience with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls)
- Preferred: Working knowledge of requirements lifecycle management tools (Helix ALM, Doors, Arena PLM)
- Preferred: Demonstrated skills in developing and introducing innovative FDA regulated medical devices to market
- Preferred: Experience with root cause analysis
- Preferred: Experience with software tools and coding (C++)
Benefits
- US base salary range: $102,825.00 - $154,237.50 (base salary only)
- Eligible for hybrid working arrangements (requires on-site work at least 1x/week; may work remotely other days)
- Estimated travel ~10% (may flex depending on business needs)
- Culture that supports a healthy work and life balance
- Equal opportunity employer commitment
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Systems Engineeringrequirements managementrisk analysistechnical designC++traceabilityverification and validationdefect triagingquality management system
Soft skills
communicationorganizational skillsprioritizationcollaboration