Senior Project Manager, Medical Devices NPI & VIP Lead

Integrated Services for Productivity & Validation, Inc; Dorado (PR); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading medical device company is seeking an experienced professional to lead strategic projects and manage cross-functional teams. The ideal candidate should have 5–7+ years in manufacturing or quality engineering within an FDA-regulated industry. Responsibilities include ensuring product quality, compliance, and overseeing new product initiatives. Strong knowledge of FDA regulations and process validation is required. This role offers opportunities for growth and impact within a dynamic organization.

Qualifications

• 5–7+ years of experience in manufacturing engineering or quality engineering within an FDA-regulated industry.
• Strong knowledge of FDA Quality System Regulation (21 CFR Part 820) and Good Manufacturing Practices (GMP).
• Experience with risk management and root cause investigations.

Responsibilities

• Provide leadership in strategic projects with site impact.
• Manage cross-functional teams for new product development.
• Ensure compliance with quality policies and project lifecycle.

Skills

Manufacturing engineering experience

Quality engineering knowledge

FDA Quality System Regulation knowledge

Collaboration skills

Job description

A leading medical device company is seeking an experienced professional to lead strategic projects and manage cross-functional teams. The ideal candidate should have 5–7+ years in manufacturing or quality engineering within an FDA-regulated industry. Responsibilities include ensuring product quality, compliance, and overseeing new product initiatives. Strong knowledge of FDA regulations and process validation is required. This role offers opportunities for growth and impact within a dynamic organization.