Burke Porter, an Ascential Technologies Brand · 1 week ago
Associate Director, Engineering
San Diego, CA
Full-time
Onsite
Lead/Staff, Director/Executive
$190K/yr - $242K/yr
10+ years expBurke Porter, an Ascential Technologies Brand, is seeking an Associate Director of Engineering to lead the technical performance and delivery of engineering projects in the life-science and medical-device sectors. This role involves providing technical direction, overseeing engineering teams, and ensuring compliance with industry standards while managing multiple engineering disciplines.
Manufacturing
Responsibilities
Direct and oversee all engineering workstreams for assigned life-science instrument and medical-device programs
Translate customer requirements into actionable engineering plans, ensuring adherence to ISO 13485, FDA design-control, and risk-management standards (ISO 14971)
Lead cross-discipline design reviews, risk analyses, and verification/validation activities for electromechanical and software-controlled systems
Ensure technical solutions integrate mechanical, fluidic, optical, electrical, and embedded-software subsystems effectively
Drive design-for-manufacture (DFM), design-for-assembly (DFA), and design-for-serviceability (DFS) best practices to enable smooth transfer to production
Serve as the key technical interface for customer engineering teams, balancing innovation with reliability and compliance
Manage and mentor a team of engineers and technical leads across multiple disciplines
Set performance expectations, conduct reviews, and foster professional growth and technical depth
Build an inclusive, collaborative culture centered on accountability, quality, and continuous improvement
Support talent development and succession planning within the engineering organization
Partner with Project Managers (PMO) to align technical deliverables, resources, and timelines
Provide input on project scoping, risk assessment, and milestone planning
Coordinate with Quality, Regulatory, Operations, and Supply Chain to ensure end-to-end technical readiness for design transfer and manufacturing scale-up
Communicate project status, risks, and technical decisions to internal stakeholders and external clients
Contribute to departmental strategy and capability building in technical areas such as system engineering, automation, optics, or mechatronic integration
Support new business pursuits through technical assessments, feasibility studies, and proposal input
Drive continuous improvement of design processes, documentation standards, and development tools
Help define and implement best practices for product realization in a CDMO environment, balancing speed, compliance, and technical excellence
Qualification
Required
Bachelor's degree in Engineering (Mechanical, Electrical, Systems, or related discipline)
10+ years in product development for life-science instruments, medical devices, or regulated electromechanical systems
Minimum 3–5 years in engineering management or technical leadership roles
Proven record delivering complex, multidisciplinary systems from concept through design transfer and production
Deep understanding of systems engineering, risk management, and design-control processes
Strong interpersonal and communication skills; ability to lead and influence across functions
Working knowledge of ISO 13485, FDA QSR, and IEC 60601 or similar regulatory standards
Competence with project-management principles (PMI or equivalent) in a matrixed PMO environment
Preferred
Master's degree
Familiarity with optics, fluidics, sensors, embedded software, or automation is advantageous
Benefits
Comprehensive benefits package
Company
Burke Porter, an Ascential Technologies Brand
Building on its history of leadership in the automotive industry, Burke Porter is now an Ascential Technologies company.
201-500 employees
H1B Sponsorship
Burke Porter, an Ascential Technologies Brand has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Growth StageTotal Funding
unknown2014-10-22Acquired
Company data provided by crunchbase