Position Summary: We are seeking a Senior Electrical Engineer who is passionate about precision, obsessive about quality, and motivated by a mission to deliver breakthrough, evidence-based therapies that transform patient outcomes. If you aspire to lead innovation in implantable medical technology, this is your opportunity to make an impact.
Essential Functions:- Lead sustaining engineering efforts for existing neuromodulation products, ensuring continued compliance, reliability, and manufacturability.
- Identify and manage EOL components, including sourcing and qualifying alternate parts.
- Redesign electrical circuits and PCBs/PCBAs to accommodate component changes and improve performance or manufacturability.
- Support verification and validation (V&V) activities for design changes, including test planning, execution, and documentation.
- Collaborate with regulatory teams to support submission updates and ensure compliance with FDA, ISO, and QSR requirements.
- Investigate field issues and manufacturing challenges, perform root cause analysis, and implement corrective actions.
- Maintain design documentation, including schematics, BOMs, layout files, and change records in accordance with quality system procedures.
- Interface with cross-functional teams, including R&D, Quality, Manufacturing, and Supply Chain, to ensure seamless implementation of changes.
- Contribute to risk assessments and design reviews, ensuring robust and compliant design modifications.
- Support supplier communications and technical evaluations for alternate components and assemblies.
- Travel up to 10%, including domestic and international visits to suppliers or manufacturing sites.
- Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
- Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
- Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Qualifications:- Bachelor's degree in electrical engineering, or related field (Master's preferred).
- Minimum 4+ years of experience in electrical engineering. Equivalent years of experience may be substituted for the education requirement.
- Experience in medical devices or other regulated industries (e.g., aerospace, automotive) is strongly preferred.
- Strong understanding of analog/digital circuit design, embedded systems, and power electronics.
- Proficiency in schematic capture and PCB layout tools (e.g., Altium Designer, OrCAD).
- Familiarity with component lifecycle management and alternate part qualification.
- Experience with V&V processes and regulatory documentation.
- Excellent problem-solving, communication, and technical writing skills.
- Working knowledge of FDA regulations, ISO standards, and QSR compliance.
- Ability to manage multiple priorities and drive projects to completion in a cross-functional environment.
Physical Demands:The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Required to sit; climb or balance; and stoop, kneel, crouch or crawl
- Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
- Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus
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.
