Project Manager

Responsibilities

• Lead strategic projects and new product launches, ensuring they meet cost, schedule, and technical goals.
• Define project goals, scope, resource estimates, timelines, and potential risks.
• Manage large, multi-site cross-functional teams and facilitate alignment across departments.
• Oversee project initiation, planning, execution, control, and close-out activities.
• Drive cross-functional communication and serve as a liaison between project teams and leadership.
• Maintain strict documentation discipline, including issue logs, metrics, and phase reviews.
• Implement New Product Engineering (NPE) methods and manage associated risks and deliverables.

Requirements

• 5–7+ years of experience in manufacturing or quality engineering within an FDA-regulated industry.
• Strong knowledge of 21 CFR Part 820, Good Manufacturing Practices (GMP), and ISO 13485.
• Proven experience supporting New Product Introduction (NPI) or New Product Development (NPD).
• Hands-on experience with risk management tools such as FMEA and hazard analysis.
• Experience working with CAPA systems and root cause investigations.
• Ability to collaborate effectively with Operations, Quality Assurance, Regulatory, R&D, and Supply Chain teams.

Preferred Qualifications

• PMP Certification is strongly recommended.

About the Company

Avante Engineering LLC was founded in 2019 with a vision centered on delivering a personalized approach to engineering and technical services to our clients. We provide expert consultation, project management solutions, and technical services across various industries.