Senior Systems Engineer — Medical Device (Onsite)

Pyramid Consulting, Inc; San Diego (CA); On-site; USD 143,270,000 - 171,924,000; Full time

Benefits offered by this job

Health insurance

Job summary

Pyramid Consulting, Inc. is seeking a Senior Systems Engineer for a 6+ month contract in San Diego, CA, onsite. You will translate stakeholder needs into system requirements and manage the development of medical devices or regulated products.

The role requires strong experience in requirements traceability, DFSS, and cross-functional collaboration to ensure FDA audit readiness and successful verification and validation.

Qualifications

• Bachelor’s degree in biomedical, mechanical, or electrical engineering; Master’s/PhD preferred.
• Minimum 5 years as a systems engineer in medical device, aerospace, or defense industries.
• Strong requirements management and traceability experience.
• Experience with DFSS and FDA audit readiness.

Responsibilities

• Translate stakeholder needs into system requirements and design specifications.
• Ensure traceability from needs through verification for FDA audits.
• Lead hazard identification and mitigation.
• Write design verification protocols and conduct design validation.
• Lead feasibility studies and risk assessments for new directions.
• Facilitate cross-functional issue resolution and apply DFSS best practices.

Skills

Systems engineering

Requirements management

DFSS

FDA audit readiness

Education

Bachelor’s degree in engineering/science

Master’s or PhD preferred

Tools

DOORS

TFS

JIRA

JAMA

Confluence

Polarian

Cockpit

Job description

Pyramid Consulting, Inc. is seeking a Senior Systems Engineer for a 6+ month contract in San Diego, CA, onsite. You will translate stakeholder needs into system requirements and manage the development of medical devices or regulated products.

The role requires strong experience in requirements traceability, DFSS, and cross-functional collaboration to ensure FDA audit readiness and successful verification and validation.