Sr Hardware Systems Engineer at DivIHN Integration Inc

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

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Title: Sr Hardware Systems Engineer
Location: San Diego, CA
Duration: 5 Months

Job 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:
1. 5 years of experience in hardware systems engineering, with at least 2 years specifically focused on wearable medical devices.
2. Demonstrated experience in authoring and managing hardware requirements using Jama Connect.
3. Strong understanding of hardware design principles for wearable devices, including patch overlay design, sensor integration, and miniaturization techniques.
4. Experience with risk management processes (e.g., FMEA) and their application to medical device development.

Required Skills (top 3 non-negotiables):
1. Proven experience authoring and managing hardware requirements in Jama Connect
2. Strong understanding of hardware design principles for wearables (patch overlay, sensor integration, miniaturization)
3. 5 years experience in hardware systems engineering, with 2 focused on wearable medical devices

Preferred Skills (nice to have)
1. Experience with statistical analysis and data interpretation
2. Experience with CGM technology or other medical device development
3. 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.

What other business units will this person interact with?
System Engineers, Quality, Regulatory, SW VandV test teams etc.

About us:

DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.