Chemist II

Chemist II/Project Lead responsible for leading cross-functional projects involving injection-molded components, tooling, NPI, and design transfer within a highly regulated environment. Coordinates global project teams, manages schedules and deliverables, resolves technical and operational issues, and supports manufacturing readiness. Ensures compliance with ISO 13485, ISO 14971, FDA GMP, and 21 CFR Part 820, while utilizing systems such as Agile PLM, SAP/BPCS, Smartsheet, JIRA, and Microsoft Excel to support project execution, quality, and continuous improvement.

• Bachelor's degree in engineering with a minimum of 7 years of experience in a regulated environment, OR an advanced degree with a minimum of 4 years of experience.
• Minimum of 7 years of professional experience in a relevant field
• Experience with Agile PLM and SAP or BPCS ERP systems
• Experience with NPI and design transfers deliverables for injection molded components
• Experience within highly regulated industry
• Hands-on experience within production and enterprise environment`
• As a Project Lead within the Mold & Capital Tooling Organization, you'll play a pivotal role on a global enterprise team, collaborating with various sites around the world. In this role, you'll lead multiple projects ensuring the seamless release of high-quality injection molded components that drive our mission forward.
• Leads cross functional teams to evaluate, develop and manage projects for key business processes.
• Leads ongoing projects and serves as liaison between project management and planning, project team, and line management.
• Reviews status of projects & manages schedules, escalate issues & prepares status reports.
• Should be able to solve a variety of problems throughout all stages of a project. Issues that may need to be solved could involve team members, clients or stakeholders related to the project.
• Being able to think on your feet and address disputes and problems is key to ensuring the project is completed in an efficient and timely manner.
• Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives.
• Knowledge of ISO 13485, FDA GMP, ISO 14971, FDA CFR 820
• Excellent written and verbal communication skills including presentation skills.
• Stronge experience in Microsoft excels, Smartsheet's, JIRA