For further inquiries regarding the following opportunity please contact one of our Talent Specialist Amit
Muskan
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 shelflife reliability and biocompatibility.
Develop and maintain hardware architecture diagrams interface specifications and systemlevel design documents.
Collaborate with crossfunctional 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 hardwarerelated 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 nonnegotiables):
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 systemlevel design.
What other business units will this person interact with
System Engineers Quality Regulatory SW V&V test teams etc.