Position Summary:

The Sr. Electrical Engineer plays a key leadership role in the design and development of a Class III implantable neuromodulation system for deep brain stimulation (DBS). In this role, you will be leading the technical team to make key and impactful decisions for electrical components in the system.

We are seeking an 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 the design and development of Class III implantable neuromodulation systems, associated accessories, test systems, and manufacturing fixtures.

• Design and analyze electronic circuits, including:

  • Embedded systems and firmware interfaces

  • Mixed-signal analog/digital circuits

  • Power management and charging circuits

• Own schematic design, PCB layout, component selection, BOMs, characterization, and system integration across all development stages.

• Establish electrical product requirements and specifications

• Design and execute experiments to validate concepts, develop new test methods, and generate design data.

• Characterize and verify hardware performance to ensure medical-grade precision and reliability.

• Drive design-for-reliability and manufacturability improvements.

• Train and mentor contract manufacturing engineers and technicians on product testing and troubleshooting methods.

• Participates in the design and execution of verification testing protocols, methods and reports to ensure products meet design requirements

• Supports risk management documentation including hazard analysis and failure modes and effect analysis (FMEA) to identify and mitigate design and process risks

• Partner closely with system, firmware, mechanical, and test engineering teams to ensure full system integration and performance alignment.

• Contribute to the company’s intellectual property portfolio through innovative concepts and technical disclosures.

• Operate in compliance with design controls and quality system procedures.

• Prepare technical reports, presentations, and design reviews for management and cross-functional stakeholders.

• Communicate with physicians and other clinicians on product design and development activities and gather feedback on product prototypes

• Collaborate with Marketing, Regulatory, and Quality to ensure design inputs and verification activities align with product and business objectives.

• 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 with 8 years, Master’s degree with 6 years, or PhD with 3 years of related experience with development or verification in the medical device industry (Class III medical device experience preferred).

• Minimum 5 years of experience in a regulated industry; medical device experience strongly preferred.

• Mostly self-directed. Determines and pursues courses of action necessary to obtain desired results. (Recommendation of assignments is often self-initiated.)

• Strong analytical and problem-solving skills.

• Strong communication and presentation skills with the ability to influence cross-functional decisions.

• Ability to thrive in a fast-paced, multidisciplinary environment.

• Ability to travel approximately 10% of the time domestically and internationally.

• Strong expertise in embedded system design, mixed-signal electronics, and power electronics.

• Understands and can operate within a highly regulated environment following industry technical and test standards as well as good documentation and laboratory practices.

• Highly self-directed; determines and pursues courses of action necessary to achieve desired results. Often initiates assignments independently.

• Demonstrated ability to plan, develop, coordinate, and direct significant engineering programs or multiple smaller projects with complex features, leveraging both internal and external resources.

• Applies advanced technical principles, theories, and concepts to solve complex problems, while developing new methodologies and approaches that deliver innovative and ingenious solutions.

• Proactively identifies developmental risks and communicates mitigation strategies effectively to management.

• Fosters a culture of collaboration and open communication across all levels of the organization. Serve as a technical consultant to the project team, helping solve challenging design issues, providing training, and bridging knowledge across disciplines.

• Working familiarity with FDA submission processes, ISO standards (13485), and Quality System Regulation (QSR) requirements.

• Experience working with relevant product development standards, guidelines, and regulations (60601, 14708, 14971, FCC)

• Experienced in software engineering, with the ability to guide firmware development or create hardware-characterization tools (languages such as C, Assembly, and Python).

Physical Demands:

The physical demands listed here are representative of those that must be met by and 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.