Principal Electrical Engineer

Element Science•Redwood City, CA

10h•$180,000 - $200,000

About The Position

Element Science, Inc. is a medical device and digital health company developing solutions for patients with heart disease as they transition from hospital to home. Its wearable patch defibrillator is designed for patients at temporary elevated risk of sudden cardiac arrest. As the company moves from development into early commercialization, the Principal Electrical Engineer serves as the senior technical subject matter expert for electrical design and manufacturing integrity of commercially released Class III products. The role helps maintain marketed devices’ safety, reliability, compliance, and cost-effectiveness throughout their lifecycle by resolving production issues, leading test strategy, managing component obsolescence, and driving continuous improvement at internal and external manufacturing sites. The position works across Manufacturing, Quality, Regulatory Affairs, R&D, Supply Chain, and Commercial Operations. The role leads manufacturing test strategy and development for released electrical assemblies, including printed circuit board assemblies (PCBAs), sub-assemblies, and finished devices. It also leads investigations into test failures and non-conformances, coordinates with suppliers and manufacturers on technical issues, supports audits and inspections, and helps transfer new products and processes into manufacturing. Periodic international travel to Thailand and Malaysia is required. The position is based at a company headquartered in the San Francisco Bay Area; the work location type is not specified. The position requires a bachelor's degree in Electrical Engineering, Electronics Engineering, or a related field; comprehensive Altium experience; and 10 or more years of electrical engineering experience, including at least five years in a regulated medical device environment and substantial experience supporting released products in manufacturing. The stated pay range is $180,000–$200,000, based on experience and qualifications.

Requirements

Bachelor's degree in Electrical Engineering, Electronics Engineering, or a related field.
Comprehensive experience with Altium creating and modifying electrical design elements.
At least 10 years of electrical engineering experience.
At least 5 years of experience in a regulated medical device environment.
Substantial experience supporting released products in a manufacturing setting.
Excellent interpersonal, writing, and verbal communication skills.
Ability to balance multiple priorities against aggressive deadlines while maintaining a high degree of quality.
Strong decision-making and problem-solving skills in a collaborative setting.
Strong technical expertise with manufacturing processes, automation, and materials.

Nice To Haves

Experience with Lean/Six Sigma tools and proficiency with statistical methodologies are preferred.
Experience with adhesives is preferred.
A background with medical device disposables and capital equipment is a plus.

Responsibilities

Design, develop, and implement manufacturing processes, equipment, and systems using engineering principles, industry standards, and working design to support robust production, human work factors, quality, and safety.
Lead test strategy and development of manufacturing test systems for released electrical assemblies, including test coverage, fixtures, automated test stations, and test software; drive test method validation and transfer to internal and external manufacturing sites.
Lead root-cause and correlation analysis of test failures and non-conformances, developing corrective actions to resolve product and process failures using Six Sigma tools and scientific and statistical expertise.
Serve as the lead subject matter expert when interfacing with external suppliers and manufacturers on component end of life, yield issues, test development, and supplier change impact assessments.
Ensure work 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; communicate technical status, risks, and recommendations to senior leadership; and mentor and provide technical guidance to engineers across departments.
Support internal and external audits and inspections by the FDA, notified bodies, and customers as a technical representative.
Support R&D Engineering in transferring new products and processes into manufacturing.
Accommodate periodic international travel to Thailand and Malaysia.
Perform other duties as assigned.