Electrical Engineer

Medical Engineering Consultants (MEC); California (MO); On-site; USD 90,000 - 140,000; Full time

Job summary

Medical Engineering Consultants (MEC) seeks an Electrical Engineer for a contract position in Orange County, California, to advance integration of medical device technologies within a regulated framework.

The role includes identifying compliance gaps, contributing to design and risk management, and producing robust engineering documentation while collaborating with partners. Travel up to 10% locally may be required.

Qualifications

• Strong written and verbal communication, judgment, decision-making, collaboration, and critical thinking skills.
• Personal drive, accountability and bias for action.
• Must have medical device experience (preferred) and work in a regulated environment.

Responsibilities

• Identify gaps in compliance and define strategy to close them.
• Input to project goals and progress; recommend revisions as needed.
• Communicate progress, risks and trade-offs of technical deliverables to leadership.

Skills

Communication skills

Judgment and decision-making

Collaboration

Accountability

Education

BS or higher in Electrical Engineering

Tools

LTspice

Altium

RF Design

Schematic capture

Job description

Job 2843 - Electrical Engineer Contract located in Orange County, California

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.
MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).
MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.
Applicants must be authorized to work in the U.S. in accordance with applicable law. This position is not eligible for employer-sponsored work authorization now or in the future.

Onsite

Key Responsibilities

• Identifying gaps in the acquired company's compliance to our Client's 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 Client's 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 our Client'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.
  

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
  

• Sponsorship is not available for this position
  

Check us out at www.medicalengineeringconsultants.com
AAP/EEO DFWP
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.