Job Title: Software Systems Engineer (Medical Devices)
Contract Duration: 7 months, possible extension
Location: Pleasanton, CA
Work Arrangement: Onsite
Pay Range: $60-$65/hour
Summary
We are seeking an experienced Software Systems Engineer to serve as both an individual contributor and team lead in the development of medical device software. This role is responsible for driving requirements, architecture, documentation, and cross-functional technical execution within a regulated environment.
Responsibilities
- Lead and contribute to software systems engineering deliverables, including:
- Requirements elicitation, decomposition, and traceability
- Development and maintenance of trace matrices
- dFMEAs
- SysML and software architecture
- Development plans and trade-off studies
- Lead technical software design reviews for assigned deliverables
- Own and author high-quality internal design documentation for use by engineers and business stakeholders
- Validate the effectiveness of implemented design patterns and documentation; continuously improve engineering practices
- Self-direct and coordinate implementation activities, project tasks, device documentation, and cross-training of team members
- Stay current on emerging software and infrastructure technologies and provide recommendations where applicable
Required Experience & Qualifications
- 5+ years of Systems Engineering experience
- Proven experience as a Software Systems Engineer within a Medical Device company
- Strong experience in software requirements development and management
- Medical device experience is required
- Experience working within an Agile development lifecycle
- Hands-on experience with requirements management tools
- Working knowledge of regulated standards and frameworks, including:
- FDA 21 CFR 820
- EU MDR
- ISO 13485
- ISO 14971
- IEC 62304
- Ability to work effectively in a geographically distributed environment
- Demonstrated ability to operate as both a team lead and individual contributor
- Strong verbal and written communication skills, with the ability to communicate across multiple organizational levels
- Ability to multitask, prioritize, and meet deadlines in a fast-paced, evolving environment
- Reliable, regular, and predictable attendance
Education
- Bachelor’s degree required
Additional Details
- Local candidates preferred
#INDPRO
#LI-SD1