Project Engineer

The Project Engineer is responsible for leading and executing medical device manufacturing and product development projects. This role ensures timely delivery of projects within scope and budget, while complying with FDA Quality System Regulations and ISO 13485 standards. The position supports LSO in producing high-quality products efficiently and cost-effectively.

Client Details

Our Client is a U.S.-based medical device contract manufacturing organization (CMO) providing end-to-end services that help medical device and life science companies bring products to market.

Description

• Manage all phases of new product development and manufacturing transfer projects, from initiation to production.
• Perform hands-on design work for products and tooling using CAD (SolidWorks), 3D printing, and machining tools.
• Act as the main point of contact between internal teams and customers to align on goals, deliverables, and timelines.
• Create and maintain project documentation, including schedules, budgets, resource plans, and risk assessments.
• Coordinate cross-functional efforts among R&D, Quality, Regulatory, Manufacturing, Marketing, and Supply Chain.
• Oversee new production line setups, including procedure development, line clearance, and operator training.
• Provide training and support for manufacturing processes and quality systems (FDA QSR, ISO 13485).
• Ensure accurate completion of work orders and manufacturing documentation.
• Support validation activities such as IQ/OQ/PQ/PPQ, TMV, and process characterization.
• Drive continuous improvement in project execution and quality systems.
• Report project status, risks, and mitigation strategies to stakeholders and leadership.
• Mentor junior engineers and enhance team capabilities.
• Collaborate with suppliers to resolve issues and improve performance.
• Identify cost-saving opportunities through process optimization and lean initiatives.
• Contribute to SOPs, work instructions, and training materials.
• Ensure compliance with EHS standards and promote a safety-first culture.

Profile

• Bachelor's degree in Mechanical, Biomedical, Systems Engineering, or related field.
• At least 7 years of experience in regulated medical device manufacturing or product development.
• Strong project/program management experience.
• Proficiency in Microsoft Office, project management tools, and SolidWorks.
• Excellent documentation, organizational, and communication skills.
• Knowledge of FDA regulations, ISO 13485, GMP, and common medical device manufacturing processes (e.g., thermoforming, sealing, labeling, packaging).
• Hands-on approach with a strong sense of ownership and craftsmanship.

Job Offer

• Competitive salary ranging from $120,000 to $10,000 per year.
• Comprehensive benefits package available
  

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.