Bachelor's degree in Electrical Engineering or related field
7+ years of progressive engineering experience in the medical device or regulated industry
Proven track record leading complex product development efforts
Strong experience in electrical hardware development including microprocessor-based systems
Experience with FDA design controls and ISO 13485
Familiarity with risk management methodologies such as FMEA and DOE
Excellent leadership and communication skills
Responsibilities
Serve as the technical lead and system architect for complex development programs
Provide technical direction and mentoring to electrical engineers
Drive product lifecycle development from concept to production
Lead development of electrical hardware and integrated subsystems
Identify risks early and implement effective mitigation strategies
Ensure compliance with FDA, ISO 13485, and global regulatory standards
Contribute to the development of the Annual Operating Plan (AOP) and align engineering deliverables with business priorities
Benefits
Opportunity to lead and mentor a team in a dynamic and innovative environment
Engagement in full product lifecycle, from concept to market
Involvement in cross-functional collaboration to influence technology strategy
Culture of continuous improvement and engineering excellence
Potential for professional growth within a regulated industry
Full Job Description
Essential Job Functions: Technical Leadership & Direction
Serve as the technical lead and system architect for complex development programs by defining and evaluating system-level designs, trade-offs, and engineering approaches
Provide technical direction, work guidance, and development to all electrical engineers while fostering a culture of continuous improvement
Lead design reviews and ensure alignment with performance, cost, safety, and regulatory requirements
Mentor and guide engineers and technical staff across the organization
Promote best practices, design consistency, and engineering excellence
Product Development Execution
Drive full product lifecycle development from concept to production
Lead development of electrical hardware and integrated subsystems
Identify risks early and implement mitigation strategies (e.g., FMEA, testing, modeling)
Contribute across multiple concurrent programs of high complexity
Engineering Rigor & Compliance
Develop and review key technical documentation including design specifications, verification and validation protocols, DOE, FMEA, and statistical analyses
Ensure compliance with FDA Design Controls, ISO 13485, and applicable global regulatory standards
Support design transfer, manufacturing readiness, and post-market improvements
Strategic & Business Contribution
Contributes to Annual Operating Plan (AOP) development, including project planning, resource needs, and technical roadmaps
Supports execution against AOP commitments, aligning engineering deliverables with business priorities
Partners with leadership and cross-functional teams to advance technology strategy and innovation priorities
Identifies opportunities to improve product performance, cost, and platform scalability
Minimum Qualifications:
Bachelor's degree in Electrical Engineering or related field
7+ years of progressive engineering experience within the medical device or similarly regulated industry, or equivalent combination of education and experience
Required Knowledge, Skills & Abilities:
Proven track record leading complex product development efforts and problem solving
Strong experience in electrical hardware development including microprocessor-based systems. board-level design, signal processing and system integration
Proven ability to deliver products in regulated environments and experience with FDA design controls and ISO 13485 or equivalent quality systems.
Experience with computer-based simulation and analysis tools
Design verification, validation, and analysis methodologies
Risk management (FMEA), DOE, and statistical analysis
Excellent leadership, communication, and interpersonal skills
Preferred Qualifications:
Master's or advanced degree in relevant technical discipline
Experience with microprocessor-controlled medical devices
Experience supporting multiple concurrent development programs
Background in platform or system-level architecture
