Senior Manager, Manufacturing Engineering

Sr. Manager, Manufacturing Engineering

Company: Surgistar

Location: Vista, CA (On-site)

Reports To: Sr. Director, Operations

About Surgistar:  We are a division of Microsurgical Technology (MST), that develops, manufactures, and markets medical devices for the ophthalmology market. Our products are manufactured using the highest levels of care and precision at our manufacturing facility in Vista, California. We constantly evolve to meet the distinct clinical needs of ophthalmic surgeons through our dedicated partnership with surgeon-designers, bringing innovation to ophthalmology.

Job Summary

The Sr. Manager, Manufacturing Engineering has a hands-on role that leads a team to design, implement, and optimize automated manufacturing systems and processes, improving efficiency and reducing costs. This position is on-site in Vista, CA.

Key Responsibilities

• Manufacturing Engineering Leadership: Lead and mentor manufacturing engineering personnel while establishing engineering priorities, managing resources, and driving execution of strategic manufacturing initiatives.

• Metallurgical Processing & Integration: Combines chemical engineering principles with metallurgy to design, optimize, and manage metal production processes, treating raw materials to create high-value metal products and integrating them into plastic components for subsequent assembly.

• Sustaining Engineering: Lead sustaining engineering activities for released products and manufacturing processes, including root cause investigations, engineering change orders (ECOs), nonconformance resolution, CAPA support, yield improvement, cost reduction initiatives, and continuous improvement projects.

• Process Improvement & Optimization: Utilize Lean Manufacturing, Six Sigma, and 5S methodologies to eliminate bottlenecks, improve workflow, increase throughput, reduce waste, and enhance manufacturing efficiency.

• Testing & Troubleshooting: Conduct validation, testing, and commissioning of systems to ensure performance, safety, reliability and regulatory compliance.

• Prototyping & Testing:  Support new product introduction and product improvement initiatives through prototype development, verification and validation testing, and data analysis.

• ​Documentation & Training: Create and maintain technical documentation, including schematics and user guides, manufacturing work instructions, process documentation and engineering reports. Train staff on new equipment, processes, and manufacturing best practices.

• Quality & Compliance: Ensure compliance with ISO 13485 and FDA regulations, managing documentation for design history files (DHF) and validation.

Required Skills & Qualifications

• Bachelor’s degree in Engineering (Metallurgical, Mechanical, Manufacturing, or related field.

• 7+ years of manufacturing engineering experience, within a regulated manufacturing environment (medical device preferred).

• Prior supervisory and management experience with responsibility for developing teams, managing performance, and leading engineering initiatives.

• Demonstrated technical leadership and project management experience leading cross-functional initiatives and driving results.

• Experience in sustaining engineering, including engineering change orders (ECOs), root cause analysis, nonconformance investigations, CAPA support, and continuous improvement of released products.

• Proficiency in CAD software (e.g., SolidWorks), GD&T, and knowledge of materials used in medical device manufacturing, including plastics and metals.

• Experience with automation and manufacturing systems, including specification, commissioning, troubleshooting, and process optimization.

• Experience supporting New Product Introduction (NPI), design transfer, and Design for Manufacturability (DFM).

• Strong knowledge of Lean Manufacturing, Six Sigma, 5S, and other continuous improvement methodologies. Lean Six Sigma certification preferred.

• Excellent communication skills for coordinating with cross-functional teams, stakeholders, and clients.

• Strong critical thinking and analytical skills to resolve complex technical issues during production.

• Knowledge of safety standards, compliance requirements, and CI/CD tools. Medical Device Regulations - ISO13485 is a plus.

• Strong critical thinking and analytical skills to resolve complex technical issues during production.

Work Environment

• Manufacturing, process development, product development, prototyping, and office environments, including automation systems, metallurgical processing operations, chemical processing, and regulated medical device manufacturing settings.

Key Performance Indicators (KPIs)

• Engineering PDP/NPI Project schedule and budget adherence

• Machine/System uptime and reliability.

• Automation adoption rate and efficiency gains.

• Overall Equipment Effectiveness (OEE).

• Cycle time reduction and production throughput.

• Cost reduction (operational and material costs).

Compensation (California Pay Transparency):
The good‑faith annual base salary range for this position is $140,000 – $185,000 at the time of posting. Actual compensation will be determined based on job‑related factors permitted by law, such as relevant experience, education, knowledge, skills, abilities, and internal equity.

Benefits:
This position is eligible for a comprehensive benefits package, subject to plan terms and eligibility requirements.

EEO/AA: Surgistar is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin (including ancestry), sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), sexual orientation, gender identity or expression, age, marital status, medical condition, genetic information, disability, protected veteran status, or any other characteristic protected by applicable law. Surgistar will not retaliate against applicants or employees for exercising rights protected by law, including requesting pay scale information.

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