Project Engineer (I-III)

Ensera; Lakeland (FL); Presencial; USD 80.000 - 120.000; Jornada completa

Descripción de la vacante

Ensera is seeking a Project Engineer (I-III) to lead technical projects and drive cross-functional execution across the full SDLC. You will manage resources, schedules, and risks while ensuring PMI stage gate quality and on-time delivery in a manufacturing environment.

Your role includes developing and validating processes, coordinating with vendors, and maintaining comprehensive project documentation to meet QA/regulatory requirements. Strong communication and regulatory knowledge are essential.

Formación

• Bachelor’s degree in engineering, science and technology.
• 5+ years in manufacturing with Process/Product development in Medical Device or Pharmaceutical Packaging including serialization, assembly, cleaning.
• Regulatory environment experience in Medical device, Pharmaceutical, Bio-Tech or Food.
• Excellent written and oral communication skills.
• Knowledge of FDA, GMP, ISO 13485 and other industry standards.
• Ability to manage multiple priorities and meet deadlines.
• Proficient in MS Suite and Statistics Software (Minitab).
• Self-directed and detail oriented with analytical skills.
• Good organizational skills and team experience.
• Excellent verbal and written communication skills.

Responsabilidades

• 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 processes and QA/regulatory requirements.
• Coordinate with vendors to track risks and ensure timely delivery.
• Develop project plans, design strategies, and validation plans; track progress.
• Prepare materials specs, product structures, process routing and equipment requirements with related docs.
• Develop and report IQ, OQ, PQ where appropriate.
• Support tooling, equipment and materials control.
• Communicate effectively with project members, customers, suppliers.
• Ensure compliance with policies and regulatory procedures.
• Execute design reviews, risk assessments, quality plans, supplier assessments.
• Support manufacturing efficiency improvements and product quality.
• Assist in design and validation for medical device and pharma manufacturing.
• Provide engineering support to manufacturing floor and other departments.
• Other duties as assigned by Program Manager.

Conocimientos

Communication skills

MS Office

Minitab

Multitasking

Teamwork

Educación

Bachelor’s degree in engineering/science/technology

Herramientas

MS Office Suite

Statistics software

Regulatory knowledge tools

Descripción del empleo

The role of Project Engineer (I-III) is to provide technical and project management leadership in the delivery and support of technical projects, driving cross-functional execution, managing resources and schedules, and ensuring adherence to PMI stage gate quality and control guidelines throughout the full systems development life cycle. This role is also responsible for leading the management of issues, risks, and project change requests to ensure successful, on-time project delivery, while contributing to process improvement initiatives across the business.

The Project Engineer (I-III) is responsible for supporting day-to-day project execution activities and helping ensure the project produces the required quality deliverables within the specified constraints of time and cost, while achieving the potential benefits defined in the business case.

Duties & 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.
• Responsible for the Development, Execution and Reporting of IQ, OQ, PQ where appropriate.
• Support development, ordering and control of process related tooling, equipment 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.
• Other duties as assigned by the Program Manager.

Education/Skills Preferred

• Bachelor’s degree in engineering, science and technology.
• 5+ years of experience in a manufacturing environment with experience in Process/Product development with Medical Device or Pharmaceutical Packaging knowledge including; Serialization, Assembly, and 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 Statistics Software (Ex. Minitab).
• 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.

We’re seeking talented individuals, creative thinkers and problem solvers to collaborate with some of the world’s leading healthcare brands

If you want to be part of a contract design and manufacturing organization that thinks outside the box, or you’re passionate about advancing healthcare solutions, we’d love to hear from you.