Technical Project Manager – New Product Development (NPD)

Zenith Services Inc.; Palo Alto (CA); On-site; USD 130,000 - 190,000; Full time

Job summary

Zenith Services Inc. is seeking an experienced Technical Project Manager with a strong Mechanical Engineering background to lead New Product Development (NPD) projects in a pharmaceutical manufacturing environment.

The ideal candidate will manage end-to-end projects, coordinate cross-functional teams, ensure regulatory compliance, and drive manufacturing readiness. A background in FDA-regulated environments and 3-5 years in PM is preferred.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• 8-15 years of engineering experience, including 3-5 years in technical project management.
• Strong experience in Mechanical Engineering and NPD/NPI.
• Knowledge of CAD tools such as Siemens NX, SolidWorks, Creo, or CATIA.
• Experience with DFM, GD&T, FMEA, and design validation.
• Knowledge of FDA regulations, GMP, regulatory compliance, and quality management systems.
• Experience with regulatory documentation, change control, CAPA, and validation.

Responsibilities

• Lead end-to-end NPD/NPI projects from concept through design, development, testing, validation, and production launch.
• Manage project timelines, budgets, resources, risks, and deliverables.
• Coordinate mechanical design, manufacturing, quality, regulatory, validation, and supply chain teams.
• Oversee mechanical product development, prototyping, and design reviews.
• Drive Design for Manufacturing (DFM), Design for Assembly (DFA), and manufacturing readiness.
• Ensure compliance with FDA regulations, GMP, and applicable industry standards.
• Coordinate regulatory documentation, design controls, risk assessments, and change control processes.
• Support audits, CAPA, deviations, validation activities, and regulatory submissions, as applicable.
• Manage engineering changes, technical documentation, and stakeholder communication.

Skills

Project management

Cross-functional leadership

Regulatory compliance

Risk management

GMP knowledge

FDA regulations

Education

Bachelor's in Mechanical Engineering

Tools

Siemens NX

SolidWorks

Creo

CATIA

Job description

Technical Project Manager - New Product Development (NPD)

Domain: Pharmaceutical / Manufacturing

Job Description:

We are looking for an experienced Technical Project Manager with a strong Mechanical Engineering background to lead New Product Development (NPD) projects in a pharmaceutical manufacturing environment.

The ideal candidate should have experience managing engineering projects, manufacturing processes, regulatory compliance, and product development within FDA-regulated environments.

Key Responsibilities:

• Lead end-to-end NPD/NPI projects from concept through design, development, testing, validation, and production launch.
• Manage project timelines, budgets, resources, risks, and deliverables.
• Coordinate mechanical design, manufacturing, quality, regulatory, validation, and supply chain teams.
• Oversee mechanical product development, prototyping, and design reviews.
• Drive Design for Manufacturing (DFM), Design for Assembly (DFA), and manufacturing readiness.
• Ensure compliance with FDA regulations, GMP, and applicable industry standards.
• Coordinate regulatory documentation, design controls, risk assessments, and change control processes.
• Support audits, CAPA, deviations, validation activities, and regulatory submissions, as applicable.
• Manage engineering changes, technical documentation, and stakeholder communication.

Required Skills & Qualifications:

• Bachelor's degree in Mechanical Engineering or related field.
• 8-15 years of engineering experience, including 3-5 years in technical project management.
• Strong experience in Mechanical Engineering and NPD/NPI.
• Knowledge of CAD tools such as Siemens NX, SolidWorks, Creo, or CATIA.
• Experience with DFM, GD&T, FMEA, and design validation.
• Knowledge of FDA regulations, GMP, regulatory compliance, and quality management systems.
• Experience with regulatory documentation, change control, CAPA, and validation.
• Pharmaceutical, medical device, or FDA-regulated manufacturing experience preferred.
• Strong project management and cross-functional leadership skills.