Senior Manufacturing Manager San Diego, CA

Senior Manufacturing Manager

Senior Manufacturing Manager San Diego, CA

Requirements

Qualifications:

Bachelor's degree in Engineering, Manufacturing, Operations Management, or a related field. Minimum of 10 years plus of progressive experience in manufacturing operations, with at least 3-5 years in a leadership role within the medical device industry. Proven experience in a highly regulated environment (FDA/ISO 13485) is required; experience with combination products or electro-mechanical devices is a strong plus. Experience in high-volume manufacturing scale-up and commercial launch is highly desirable. Experience in early-stage, startup, or high-growth environment is strongly preferred. Experience scaling manufacturing from pilot to higher volume preferred. Deep knowledge of Lean Manufacturing, Six Sigma (Green or Black Belt preferred), and process validation. Strong understanding of production planning, ERP/MRP systems (e.g., SAP, Oracle), and inventory management principles. Demonstrated ability to lead, inspire, and develop teams through periods of rapid growth and change. Excellent problem-solving, analytical, and decision-making skills with a hands-on, "in the trenches" leadership style. Outstanding communication and interpersonal skills, with the ability to collaborate cross-functionally with R&D, Quality, and Commercial teams. Demonstrated Evidence being a strong team builder with integrity, resilience, curiosity and empathy. Soft Skills: High ownership mindset; comfortable with ambiguity and change; strong decision-making; ability to influence without authority; calm and solution-oriented under pressure; strong communication across technical and non-technical audiences; emotional intelligence and strong people judgment; grow mindset and learning agility. Supervisory and Leadership Skills: Performance management and coaching capability; conflict resolution and employee relations judgment; workforce planning and staffing strategy; change management leadership; developing first-line supervisors and future leaders; leading through rapid company growth phases; building structure without creating bureaucracy. Technical Skills: Medical device or regulated manufacturing environment experience. Knowledge of: GMP/QSR/ISO quality environments; process validation concepts; manufacturing documentation systems; production planning concepts; root case analysis tools; lean manufacturing principles. Experience scaling production volume. Start-up Specific Capabilities: Builds processes from scratch; comfortable wearing multiple hats; strong prioritization skills; resourceful with limited resources; balances speed with compliance; understands when to implement structure vs remain flexible. Knowledge Requirements: Regulated manufacturing lifecycle; production flow and material control; capacity modeling and production scaling; workforce skill development and training systems; risk-based decision making; audit readiness and documentation discipline.

Working Place: San Diego, CA, USA

Company: ESR Healthcare