We are seeking a highly experienced Electrical Engineer to lead and independently manage the qualification of alternate electronic and mechanical components for medical devices. This role requires a strong background in electrical engineering, medical device regulatory standards (FDA, ISO13485), and experience working with cross-functional teams. The candidate will review technical specifications, perform change impact assessments, and collaborate closely with R&D, Regulatory, and Quality Assurance teams. The focus is on tasks performed rather than job titles, making relevant hands-on experience critical.

Key Responsibilities:

• Lead the qualification of alternate electronic and mechanical components for medical products based on recommendations from Corporate or Third-Party Manufacturers (TPMs).
• Independently review technical specification sheets and perform comprehensive technical assessments to provide justification for component changes.
• Develop and document change impact assessments, working closely with R&D to ensure the accuracy of technical justifications.
• Collaborate with cross-functional teams (Regulatory, Quality Assurance, R&D, Operations, and Global Sourcing) to review and validate component changes.
• Serve as the Subject Matter Expert (SME) or Independent Technical Expert (ITE) on project-related technical matters.
• Ensure compliance with cGMP, FDA, and ISO13485 standards in all engineering and documentation tasks.
• Use engineering tools like oscilloscopes and schematics to review 75% of components off data sheets, while handling 25% customized components.
• Coordinate internal resources to meet project goals, ensuring alignment with company business needs, customer requirements, and clinical needs.
• Communicate effectively with senior management and external agencies when required.
• Complete all project-related documentation on time, adhering to corporate policies and business standards.
• Lead or participate in cross-functional team reviews, providing technical expertise and driving project success.

Required Qualifications:

• Bachelor’s Degree in Electrical Engineering (mandatory, no other degrees will be considered).
• Minimum 5+ years of hands-on experience in the medical device industry (internships, co-ops, and school projects will not be considered).
• In-depth knowledge of cGMP, FDA, and ISO13485 standards.
• Medical device regulatory experience is required; no other regulatory experience will be accepted.
• Strong knowledge of engineering principles, with extensive understanding of design and manufacturing processes for medical devices, particularly handheld devices.
• Excellent written and verbal communication skills, with a patient and detail-oriented approach.
• Ability to work independently and lead cross-functional teams, providing strong leadership in technical decision-making.
• Familiarity with using oscilloscopes and other tools to handle both off-the-shelf and custom components.

Top Skills to Highlight on Resume:

• Electrical Engineering degree
• 5+ years of experience in the medical device industry
• Expertise in FDA and ISO13485 standards

Pay Range: $50/hr to $60/hr