Principal Electrical Engineer

Summary of Role

The Principal Electrical Engineer is the senior technical subject matter expert for the electrical design and manufacturing integrity of commercially released Class III products. This role keeps marketed devices safe, reliable, compliant and cost-effective throughout their lifecycle by resolving production issues, leading test strategy efforts, managing component obsolescence, and driving continuous improvement at both internal and external manufacturing sites. The Principal works across Manufacturing, Quality, Regulatory Affairs, R&D, Supply Chain, and Commercial Operations.

Responsibilities

• Design, develop, and implement manufacturing processes, equipment, and systems using knowledge of engineering principles, industry standards, and working design to ensure robust production processes, human work factors, quality, and safety standards.
• Lead test strategy and development of manufacturing test systems for released electrical assemblies (PCBAs, sub-assemblies, and finished devices), including test coverage, fixtures, automated test stations, and test software, driving test method validation and transfer to internal and external manufacturing sites to ensure robust defect detection, yield, and compliance.
• Lead root cause and correlation analysis on test failures and non-conformances to identify and develop corrective actions for solving product and process failures using six sigma tools and scientific and statistical expertise.
• Serve as lead subject matter expert to interface with external suppliers and manufacturers on technical issues such as component end of life, yield issues, test development, and supplier change impact assessments.
• Deliver work that complies with 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601-1 and applicable collateral and particular standards (including IEC 60601-2-4), and IPC Class 3 workmanship standards.
• Lead cross-functional project teams and communicate technical status, risks and recommendations to senior leadership while mentoring and providing technical guidance to engineers across departments.
• Support internal and external audits and inspections (FDA, notified bodies, customers) as a technical representative.
• Support R&D Engineering to transfer new products & processes into manufacturing.
• Accommodate periodic international travel to Asia (Thailand, Malaysia).
• Perform other duties, as assigned.

Qualifications

• B.S. in Electrical Engineering, Electronics Engineering, or a related field required.
• Comprehensive Altium experience creating and modifying electrical design elements.
• 10+ years of electrical engineering experience, with at least 5 years in a regulated medical device environment; substantial experience supporting released products in a manufacturing setting.
• Experience with Lean/Six Sigma tools and proficiency with statistical methodologies preferred.
• Excellent interpersonal, writing, and verbal communication skills.
• Demonstrated ability to balance multiple priorities against aggressive deadlines while maintaining a high degree of quality.
• Strong decision-making ability and problem-solving skills within a collaborative setting.
• Experience with adhesives preferred and background with medical device disposables and capital equipment a plus.
• Strong technical expertise with manufacturing processes, automation, and materials.