Job description

Position Summary

The role of the Project Engineer is to help deliver 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 as it relates to improving project delivery.

The Project Engineer will also be responsible for managing specific Injection Moulding activities within the projects. They are responsible for assisting the projects Managers on a day-to-day basis. 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.

Duties & Responsibilities

• 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.

• Track and report progress against plan

• Identifies and applies best practices and needed process improvements, drives adoption and challenges standards.

• Ensures compliance with company and regulatory policies and procedures.

• Monitors project execution to deliver incremental business value.

• Participates in the creation of the master work efforts plan from the underlying plans (if applicable).

• Participates in work effort closure activities to determine benefit / business impact realization.

• Manages risk by using best risk management practices to address execution challenges associated with quality and schedule in adherence with risk management framework.

• Improve manufacturing efficiency, production yields, product quality and consistency through equipment and product design modifications and fabrication.

• Modify and improve existing equipment.

• Finalizes manufacturing methods for medical devices.

• Responsible for injection moulding activities

• Aid with equipment design for producing medical devices and components.

• Supports production and manufacturing with Injection Moulding related activities.

• Engineering support which includes; vendor contact and auditing specification.

• Contributes to team effort by accomplishing related duties as requested.

• Follow SOP on re-validation of existing equipment, tooling and processes.

• 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.

• Works with Quality Control team to generate, update and implement all project related documentation including control plans, work instructions, manufacturing procedures, sample request, process guides and troubleshooting guides.

• Other duties as assigned by the Programme Manager

• Developing and maintaining project plans, design strategies, validation plans, and other project-related activities as applicable.

• Support the selection and validation of equipment.

• Development of materials specifications, product structures, process routing and equipment requirements 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.

• Actively participate in project team meetings utilizing action plans and project timelines.

• Effectively communicate with external/internal project members, suppliers and service providers

• Control incoming and outgoing purchase orders and invoices that are relevant for projects.

• Perform and participate in design reviews, risk assessments, quality plans, supplier assessments.

• Cooperate closely with sales and marketing to achieve the best possible customer outcomes.

Qualifications, Education & Skills

• Bachelor’s Degree in Sciences or Engineering

• 3+ years of experience in an injection moulding environment – Preferred

• 2+ years’ experience as a Injection Moulding or Project Engineer – Preferred

• Medical device, Pharmaceutical and/or Biotech knowledge and regulatory experience – 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.

• Self-directed and detail oriented with an inquisitive nature and desire to solve problems.

• Good organizational skills and experience working as part of a team.

• Excellent verbal and written communication skills.

Job Type: Full-time

Pay: $70,000.00 - $75,000.00 per year

Schedule:

• 8 hour shift
• Day shift
• Evening shift
• Monday to Friday

Ability to commute/relocate:

• Plant City, FL 33563: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

jjbodyshop.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, jjbodyshop.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, jjbodyshop.com is the ideal place to find your next job.