Staff Electrical Engineer

Position: Staff Process Electrical Engineer

Location: Gaithersburg, MD

Industry: Medical Device / Active Implantables

Employment Type: Full-time

Position Overview:

We are seeking a Staff Electrical Engineer to join a growing engineering team focused on the development and manufacturing of implantable medical devices. This individual will be responsible for designing, developing, and optimizing electrical process systems with a focus on battery integration, automation, and high-reliability manufacturing. The ideal candidate will bring strong problem-solving abilities, experience with regulated environments, and a collaborative mindset.

Key Responsibilities:
• Analyze and improve electrical manufacturing processes involving battery integration into implantable sensors.
• Develop and implement automation solutions to enhance efficiency, lower costs, and improve product quality.
• Use data analytics and statistical methods to identify trends, root causes, and areas for design/process improvement.
• Lead the design, development, and validation of electrical systems and processes for medical device manufacturing.
• Collaborate with cross-functional teams including R&D, Quality, and Operations to ensure seamless process integration.
• Support technical transfer and scale-up efforts with contract manufacturing organizations (CMOs).
• Ensure compliance with applicable industry regulations including ISO 13485 and 21 CFR Part 820.
• Troubleshoot and resolve process and equipment issues during development and manufacturing.
• Conduct root cause analyses and implement corrective actions in a timely and thorough manner.
• Lead and support verification and validation (V&V) of equipment, tools, and manufacturing processes.
• Drive the development and execution of testing protocols to ensure systems meet specifications and quality standards.

Qualifications:
• Bachelor’s degree in Electrical Engineering or a related discipline.
• Hands-on experience in electrical system design and process development in a regulated manufacturing environment.
• Experience with batteries or power systems in medical device applications.
• Strong analytical skills with the ability to interpret complex data and drive data-informed decisions.
• Working knowledge of ISO 13485 and 21 CFR 820 compliance requirements.
• Demonstrated ability to lead cross-functional teams and collaborate effectively across departments.
• Proficiency in relevant engineering tools, modeling software, and automation systems (AOI experience is a plus).
• Excellent written and verbal communication skills.
• Self-starter with the ability to work both independently and as part of a high-performing team.