Electrical Design Engineer, Medical Devices -- onsite in Irvine, CA 100%

• Identifying gaps in the acquired companys 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 Scientifics 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.

Quality Systems Duties and Responsibilities:

• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Qualifications

• BS or above in Electrical Engineering or related field
• 4+ yrs of engineering experience with bachelors degree, or 2+ yrs with Masters
• 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.
• Must have medical device experience (preferred)
• Must have worked in regulated field
• Implantable medical device experience and testing highly preferred
• 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.
• Up to 10% travel -mostly local.

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