Senior Systems Engineer at Delve

Setup: Hybrid
Location: Madison, Wisconsin · Philadelphia, Pennsylvania · +2
Type: Full-time
Level: Senior

Description

Delve is seeking an experienced Senior Systems Engineer to lead product development in the medical device industry. The role involves defining system architecture, managing technical risks, translating user needs into system frameworks, and providing leadership across various design teams. Responsibilities also include collaborating with program management, ensuring regulatory compliance, and building client relationships.

Required Skills

System Architecture
Technical Risk Management
Systems Frameworks
Design Traceability
Program Management
QMS Requirements
Design Control Artifacts
Client Relationships
Concept Development
Verification and Validation
Industrial Design
Human Factors

Additional Information

Minimum Education: Bachelor’s degree in Mechanical, Electrical, Biomedical, or related field.
Required Previous Experiences: 10+ years of experience in the medical device industry, or 7+ years of experience with an advanced degree.
Experience developing FDA-regulated Class II and/or Class III electromechanical devices (or equivalent design-controlled products).
Experience driving development of connected devices/products with both firmware and software.
Experience in clinical and/or patient-care settings.
Preferred Qualifications: An experienced systems engineer with a background in regulated medical devices and familiarity with model-based systems engineering, including a working knowledge of SysML, Helix, Jira and similar development and requirements management tools.
A collaborative partner who thrives in multidisciplinary teams across early- and late-stage development, including V&V and design transfer.
A consultant with a strong customer-centric mindset and ability to effectively scope work.
A subject matter expert who can distinguish between project and user needs, formulate strategies, and lead teams to successful outcomes.
A professional committed to high standards of quality, rigor, and craftsmanship.
A self-motivated individual who can work independently with minimal oversight.
An excellent communicator with strong writing, presentation, and interpersonal skills.
A team member with an inclusive mindset who models people-centered behaviors across the organization.