Catalyst MedTech Search · 1 month ago
Systems Electrical Engineer (Sr-Principal)
Solana Beach, CA, US
Full-time
Onsite
Senior Level, Lead/Staff
$150K/yr - $200K/yr
8+ years expCatalyst MedTech Search is a company focused on developing innovative medical technologies, and they are seeking a Senior Principal Systems Electrical Engineer to lead the development of electrosurgical tools. This role involves overseeing the entire product lifecycle, collaborating with internal and external teams, and ensuring compliance with regulatory standards.
Staffing & Recruiting
Responsibilities
Technical lead for various elements of an electrosurgical system which may include the RF generator, one-time use devices, and/or system accessories through all stages of the product lifecycle
Review existing or develop •de novo• project schedules to identify strategies to de risk timelines as well as to compress timelines to meet company objectives
Interface closely with suppliers including third-party development companies and contract manufacturers on a daily basis to review project status and help eliminate technical hurdles
Prepare technical documentation, including manufacturing instructions, test methods, protocols, and reports, to support design control activities and regulatory submissions
Manage 60601 and other electrical safety and EMC, MRI safety, and radio regulation (FCC, RED, etc.) compliance activities
Test method development for both characterization testing and verification/validation testing
Support of preclinical and clinical testing
Strong verbal, written, and cross-functional communications skills
Ability to work both independently and in project team settings
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements
Qualification
Required
Bachelor's degree in Electrical Engineering (required); degrees in Mechanical Engineering or a closely related discipline may be considered if supported by substantial electrical engineering experience
Minimum 8 years in design/engineering for medical device development and/or manufacturing
Experience with full life-cycle engineering, from concept (prototyping) to production transfer, and scale-up, for an FDA-regulated Class II/III medical devices following design controls best practices
Must have prior experience with electromechanical systems / medical capital equipment
Electrical engineering background with the ability to act as the in-house EE SME, driving and reviewing design changes with external vendors and contract manufacturers to support system improvements and issue resolution
Ability to influence others and deliver effective communication in a dynamic environment
High level of independence and ability to self-manage multiple competing priorities
Preferred
Advanced degree in an engineering discipline
Experience in class II/III medical device and capital equipment development
Experience in a startup environment
Benefits
10-15% bonus
Equity
Company
Catalyst MedTech Search
Catalyst is a niche recruitment firm partnering with U.S.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase