Electrical Engineer (Irvine)

Job Title: Electrical Engineer

Location: 15515 Sand Canyon Road, Irvine, CA 92618

Duration: 8 Months Contract with Possible of extension

(Candidates must be local to Los Angeles / Orange County area)

MUST:

• Must be able to travel up to 10% during length of assignment. Mostly local travel.
• BS or above in Electrical Engineering or related field - prefer EE
• Must have medical device experience
• Implantable medical device experience AND testing
• highly collaborative individual
• Critical thinking skills
• Excellent writing and communication skills

Job Description:

• Seeking Electrical Engineer for Axonics Integration / Guardian Project with strong hands-on experience in electrical design. Please be prepared to clearly articulate your personal ownership and detailed technically.
• Multi-layer PCB and system-level design
• Failure analysis and deep debugging
• Design remediation and product refinement
• Strong documentation skills (specifications, FMEA, hazard analysis, validation reports) and medical device experience are highly preferred.

Key Responsibilities:

• Identifying gaps in the acquired company’s compliance to Boston Scientific Work Instructions and SOPs and defining strategy to close these gaps.
• Providing input to project goals and progress and recommending appropriate revisions.
• Communicating progress, risks, and trade-offs of technical deliverables to project leadership, and recommends revisions as needed.
• Completing complex or novel assignments requiring the development of new or improved techniques and procedures. Work is expected to result in efficient and effective integration of medical device technologies to the Boston Scientific portfolio.
• Successfully completing engineering work in electrical design remediation, product design refinement, preparation of specifications, test method validation, and report preparation.
• Assessing the feasibility and soundness of alternative engineering processes, products, or equipment.
• Contributing to design hazard analysis, FMEA, and ensuring compliance with Boston Scientific’s design control and risk management standard operating procedures.
• Completing clear and concise engineering documentation to facilitate knowledge transfer during product integration.
• Collaborating with external partners and suppliers to align component specifications, qualification and acceptance activities, testing protocols, and quality standards.

Qualifications:

• BS or above in Electrical Engineering or related field
• 4+ yrs of engineering experience with Bachelor’s degree, or 2+ yrs with Master’s
• Must have medical device experience
• - Implantable medical device experience and testing
• Strong electrical and/or systems engineering design documentation experience, problem-solving skills and attention to detail
• Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources
• Strong written and verbal communication, judgment, decision-making, collaboration, and critical thinking skills
• Personal drive, individual accountability & a strong bias for action.

Preferred Qualifications:

• Familiarity with IEC 14708 and 45502 Active Implantable standards
• Familiarity with IEC 60601 Electrical Medical Equipment standards
• Experience in Test Fixture Design and Implementation
• Experience in Analog and Digital Design
• Experience using LTspice or equivalent Electrical Simulator Tools
• Experience in Altium for Schematic Capture and PCB Design
• Experience in RF Design and Test
• Experience in Hands-on Electronics Troubleshooting
• Experience in medical device Design Acceptance and Design Verification testing
• Ability to build strong relationships across the organization and with external stakeholders