Our international Medical Device client with manufacturing locations in Georgia and Puerto Rico is looking for a Project Manager - Staff Engineer to be responsible for multifunctional (global) teams on an initiative involving textile engineering including plastics and polymer materials.Responsibilities:
- Lead planning, design and execution, and monitors budget, quality and planning status of part of a major project or a complete small project. Understanding project risks and putting in mitigations, where applicable.
- Be responsible for creation and/or review of required protocols/reports, specifications and routing these for approval through the document control system.
- Analyze technical requirements and recommends solutions.
- Design mechanisms and sub-assemblies of various machine and tooling systems.
- Have a proficient understanding of GMP's and ISO 9001 standards.
- Observe and promote all regulatory requirements and notify any violation or deviation.
- Assist in the development and review of production equipment and process specifications.
- Conduct troubleshooting of equipment and processes during the debug and development phases. Exhibits technical skills to make decisions in solving problems.
- Take responsibility of problems/anomalies, and required remediations.
- Provide data analysis and recommendations from testing and development protocols.
- Work with both internal, as well as external, manufacturers as well as collaborating with several functional areas and multi-functional teams.
- Be able to demonstrate your leadership, technical and intellectual skills to tackle sophisticated issues and progress projects.
Qualifications:
- A minimum of a Bachelor's Degree in Plastics Engineering, Polymer Science, Materials Science or a related technical subject area is required.
- Process Engineering experience and experience working in a regulated industry (i.e. Pharma, Medical Device) is preferred.
- Prior exposures to execution of cost improvement projects (CIPs), capacity expansion projects, new process development and process validation is preferred.
- Knowledge of the validation requirements for Medical Device manufacturing preferred.
- Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required. Knowledge of CAD preferred.
- Knowledge of statistical data analysis tools (e.g. Minitab) preferred.
- Knowledge of Six Sigma/Process Excellence Tools and Methodologies (i.e. DMAIIC, DMADV, Lean), including Design of Experiments, capability analysis and sampling statistics and techniques preferred.
- Experience in the creation and implementation of project plans is preferred.
- Strong organizational skills with the ability to oversee multiple projects required. The applicant must have excellent written and verbal communication, as well as strong interpersonal and influencing skills. The ability to collaborate in a cross-functional team environment is required.
- This position may require up to 25% domestic and international travel.
#LI-DR2