Product Development & Manufacturing Engineering Manager

About the role

Help grow a safer, cleaner, healthier future for everyone, every day. Product Development & Manufacturing Engineering Manager at Surgistar in Vista, CA (On-site).

Responsibilities

• Metallurgical Processing & Integration: Combines chemical engineering principles with metallurgy to design, optimize, and manage metal production, treating raw materials to create high-value metal products and incorporating into plastic for the next assembly.
• Create high-quality 3D CAD models, drawings, and 2D blueprints using SolidWorks or similar software, focusing on design for manufacturability (DFM).
• Create prototypes, develop verification/validation test protocols, and analyze data.
• Part creation by way of 3D printing will be required.
• Process Improvement & Optimization: Use Lean manufacturing, Six Sigma, and 5S tools to eliminate bottlenecks, improve workflow, and boost efficiency.
• Conduct validation, testing, and commissioning of systems to ensure performance, safety, and compliance with regulations.
• Prototyping & Testing: Create prototypes, develop verification/validation test protocols, and analyze data.
• Documentation & Training: Create and maintain technical documentation, including schematics and user guides, Manufacturing Work Instructions, and train staff on new equipment.
• Quality & Compliance: Ensure compliance with ISO 13485 and FDA regulations, managing documentation for design history files (DHF) and validation.

Requirements

• Bachelor’s degree in Engineering (Metallurgical, Mechanical, or equivalent experience)
• 3–10 years of product development and/or Manufacturing engineering in a regulated industry (medical devices preferred).
• Proficiency in CAD software (e.g., SolidWorks), GD&T, and knowledge of materials (plastics, metals) used in medical devices.
• Automation & manufacturing systems (specification, commissioning, troubleshooting)
• New Product Introduction (NPI) and design for manufacturability (DFM)
• Cross-functional leadership, project management, and technical communication
• Strong critical thinking and analytical skills to resolve complex technical issues during production.
• Leverage Lean Six Sigma Certification
• Excellent communication skills for coordinating with cross-functional teams, stakeholders, and clients.
• Knowledge of safety standards, compliance requirements, and CI/CD tools.
• Medical Device Regulations - ISO13485 is a Plus.

Qualifications

• Work Environment: Product development, prototyping, and manufacturing settings and offices (Automation and Chemical for metal processing).

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

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.