Project Engineer
Job Overview
We are seeking a Project Engineer to lead the planning, design, and execution of construction and facility improvement projects within the medical device industry.
This role combines technical leadership and project management, ensuring compliance with quality, safety, and regulatory standards such as GMP, FDA, and ISO 13485.
Key Responsibilities
- Lead the planning, design, and execution of construction and renovation projects, including cleanrooms, utilities, production areas, and offices.
- Manage project schedules, budgets, and resources, ensuring timely delivery of key milestones.
- Ensure full compliance with Good Manufacturing Practices (GMP), FDA, ISO 13485, and company EHS standards.
- Review and validate technical specifications, engineering drawings, and construction packages.
- Collaborate with contractors, architects, and consultants to align designs with operational and regulatory needs.
- Support commissioning, qualification, and validation activities for facility systems and utilities.
- Lead Design for Manufacturability (DFM) and product/process transfer to commercial manufacturing.
- Prepare and present technical reports, project updates, and risk assessments to senior leadership.
- Provide input on re-engineering opportunities to improve process performance and product quality.
- Mentor engineers and provide technical guidance to cross-functional teams.
- Oversee installation and validation of new or existing production lines, ensuring regulatory compliance.
Requirements
Qualifications
- Bachelor’s degree in Engineering or related field.
- 5+ years of experience as a Project or Program Engineer in the Medical Devices industry.
- Fluent in English and Spanish (minimum B2 level).
- Experience with risk management, ISO 13485, and 21 CFR Part 820 and their impact on project schedules and documentation.
- Proven experience leading validation project plans for medical device products and processes.
- Strong problem-solving, communication, and conflict management skills.
- Experience in product and process transfer projects is a plus.
- PMP certification is a plus.
- MBA is a plus.