Project Engineer

JOB SUMMARY

The role of the Project Engineer (I-IV) is to help deliver and support technical projects, manage resources, schedule and adhere to the PMI stage gate quality and control guidelines throughout the full systems development life cycle. This also includes management of issues, risks and project change requests to ensure successful and on-time project delivery. Contribute to process improvement initiatives for the business.

The Project Engineer (I-IV) is responsible for assisting on day-to-day task for project execution. Verify that the project produces the required deliverables of quality, within the specified constraints of time and cost and to achieve the potential benefits defined in the business case.

JOB RESPONSIBILITIES

• Develop, configure and optimize processes from inception through to start up and validation
• Maintain and document development plans through product development cycle.
• Comply with PMI control process and meet Quality Management System requirements.
• Communicate with external vendors to set expectations, track risks, and ensure timely delivery to meet program goals.
• Developing and maintaining project plans, design strategies, validation plans, and other project-related activities as applicable. Track and report progress against plan.
• Development of materials specifications, product structures, process routing and equipment requirements along with project related documentation including control plans, work instructions, manufacturing procedures, sample request, process guides and troubleshooting guides in accordance with QA/regulatory requirements.
• Support Development, Execution and Reporting of IQ, OQ, PQ where appropriate
• Support development, ordering and control of process related tooling and materials.
• Effectively communicate with external/internal project members, customers, suppliers and service providers
• Ensures compliance with company and regulatory policies and procedures.
• Perform and participate in design reviews, risk assessments, quality plans, supplier assessments.
• Support improvements in manufacturing efficiency, production yields, product quality and consistency through equipment and product design modifications and fabrication.
• Support Design, Selection, Modification and improvement of equipment and subsequent validation for medical device and pharma manufacturing.
• Engineering support which includes; vendor contact and auditing specification.
• Develops/improved processes, sampling activities and as well as tooling and manufacturing concepts that will meet customer expectations on cost, quality and delivery.
• Provide technical assistance and engineering support to the manufacturing floor in ensuring production of quality products. Work with other support departments to maintain on-time delivery goals.

JOB QUALIFICATIONS

• Bachelor’s Degree in Sciences or Engineering
• 5+ years of experience in a manufacturing environment with experience in Process/Product development with Injection Molding, Assembly, Cleaning knowledge – Preferred
• Regulatory environment experience - Medical device, Pharmaceutical, Bio-Tech and/or Food – Preferred.
• Excellent written and oral communication skills
• Knowledge of FDA, GMP, ISO 13485 and other industry standards – Preferred.
• Ability to organize and manage multiple priorities while consistently meeting deadlines.
• Proficient in MS Suite and CAD or AutoCad skills
• Self-directed and detail oriented with analytical skills and an inquisitive nature.
• Good organizational skills and experience working as part of a team.
• Excellent verbal and written communication skills.