Associate Director, Engineering
3 days ago
The Associate Director of Engineering leads the technical performance and day-to-day delivery of the engineering organization supporting life-science instrument and medical-device development projects within a CDMO environment. This role ensures that engineering teams deliver robust, manufacturable, and compliant designs that meet customer requirements and program objectives. The Associate Director provides technical direction, people leadership, and project execution oversight across multiple engineering disciplines—including mechanical, electrical, software, systems, and test engineering—while partnering closely with Program Management, Quality, and Operations functions. Although a dedicated PMO manages formal project scheduling and reporting, this role provides strong technical project leadership to ensure successful execution.
Key Responsibilities
Technical Leadership
- 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.
Qualifications
Bachelor’s degree in Engineering (Mechanical, Electrical, Systems, or related discipline); Master’s degree preferred.
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.
Familiarity with optics, fluidics, sensors, embedded software, or automation is advantageous.
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.
This is an on-site position in San Diego with a salary range of $190,000-242,000 annually.
Compensation is based on several factors, including experience, skills, education, and job-related knowledge. In addition to base salary, Ascential offers a comprehensive benefits package.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.
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