Job Title: Sr Hardware Systems Engineer-

San Diego, CA 92121

Duration: 5 Months contract

Pay Range: $60/hr-$70/hr on W2

Description:

Responsibilities:

Elicit, analyze, and document detailed hardware requirements for CGM wearable devices, covering aspects such as patch overlay design, mechanical robustness, electrical performance, sensor accuracy, shelf-life, reliability, and biocompatibility.

Develop and maintain hardware architecture diagrams, interface specifications, and system-level design documents.

Collaborate with cross-functional teams (e.g., mechanical engineering, electrical engineering, firmware engineering, test engineering) to ensure seamless integration of hardware components and subsystems.

Conduct risk assessments (FMEA) to identify and mitigate potential hardware-related risks.

Participate in design reviews and provide technical input to ensure that hardware designs meet requirements and specifications.

Support verification and validation activities by defining test cases and analyzing test results.

Maintain meticulous records of hardware requirements, design decisions, and risk assessments within Jama Connect.

Must Haves:

5+ years of experience in hardware systems engineering, with at least 2 years specifically focused on wearable medical devices.

Demonstrated experience in authoring and managing hardware requirements using Jama Connect.

Strong understanding of hardware design principles for wearable devices, including patch overlay design, sensor integration, and miniaturization techniques.

Experience with risk management processes (e.g., FMEA) and their application to medical device development.

Required Skills (top 3 non-negotiables):

Proven experience authoring and managing hardware requirements in Jama Connect. Experience with statistical analysis and data interpretation.

Strong understanding of hardware design principles for wearables (patch overlay, sensor integration, miniaturization)

Experience with CGM technology or other medical device development

5+ years’ experience in hardware systems engineering, with 2+ focused on wearable medical devices

Familiarity with ISO 13485 and other relevant regulatory standards

Education Requirements:

B.S. in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or a related field.

Required Testing:

• May include technical assessments related to configuration management principles, PDM/PLM software proficiency, and systems engineering fundamentals.

• Personality assessments to evaluate cultural fit.

Hardware Skills Required:

Experience with patch overlay design, sensor integration, miniaturization techniques, mechanical design, electrical component selection, and reliability testing. Understanding of hardware architecture, interface specifications, and system-level design.

Benefits Info

Russell Tobin offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, auto, home insurance, pet insurance and employee discounts with preferred vendors.