JOB SUMMARY:

The Sustaining R&D Scientist is responsible for product design improvements, testing, and analysis utilizing a variety of scientific disciplines. This role supports cross-functional initiatives, including product development, quality, manufacturing, customer service, sales, marketing, and procurement, to enhance product performance, quality, customer satisfaction, and cost-efficiency, while ensuring compliance with internal quality systems and applicable EPA & FDA regulations in the consumable medical device industry.

JOB REQUIREMENTS:

• MS in Chemistry, Biochemistry or related field.
• 5+ years of industrial laboratory experience in EPA and FDA related product development and/or manufacturing environment.
• Experienced in applying good laboratory practices (GLP) required.
• Technical knowledge in wet chemistry, formulation, and colloid & surfactant science.
• Expert in developing and validating analytical test methods using GC, HPLC, MS, and UV-Vis, with strong proficiency in troubleshooting, maintaining, and life cycle management of laboratory instrumentation.
• Experienced in laboratory automations and troubleshooting of automation programs.
• FDA Quality System Regulation Part 820 and ISO 13485 experience required.
• Experienced in design control, requirements management, design transfer, and process capability analysis.
• Up to 10% travel will be required for this position.

PREFERRED QUALIFICATIONS:

• MS in Analytical Chemistry preferred.

LI-SC1

• Develop comprehensive knowledge of existing Metrex products, from design input to design output, from raw materials to manufacturing of final products.
• Serve as the Subject Matter Expert (SME) for the assigned product categories.
• Collaborate with project team members and other functional departments to assess, verify, validate and implement product design changes to currently marketed products in alignment with internal design change procedures.
• Participate in the execution and final approval of design changes, including conducting engineering and scientific studies with written protocols and reports, performing risk assessments, and developing/executing design verification and validation protocols. Document all findings and outcomes in formal reports.
• Prepare and maintain design change documentation and ensure completeness of Design History Files (DHF) for assigned products.
• Provide support for manufacturing trouble shooting, nonconformance investigations, supplier quality issues, production interruptions, CAPAs, and product improvement initiatives.
• Investigate customer complaints, develop effective solutions, and implement corrective actions into production in accordance with internal quality system procedures.
• Deliver consistent and timely updates to all stakeholders, ensuring clear visibility into project status and ongoing progress.