Principal R&D Engineer
Stark Pharma Solutions Inc
- USA
- Permanent
- Full-time
Location: Round Lake, IL (Onsite)
Experience: 5 - 8 Years
Duration: 12+ months contract About the RoleWe're looking for a Principal R&D Engineer to join our team in Round Lake, IL. This role requires a hands-on leader who can manage technical projects, guide engineering teams, and drive product development for disposable medical devices. You'll work closely with development groups, technical support teams, and the Project Management Office to ensure successful execution of design, testing, and manufacturing activities in compliance with regulatory standards. Key ResponsibilitiesPlan and schedule project activities with minimal guidance, collaborating with development and technical support teams.Devise new approaches to complex problems by adapting and modifying standard technical principles.Supervise and coordinate the work of engineers, senior engineers, and project coordinators.Ensure sound decisions in material selection, product design, and supplier evaluation.Apply knowledge of manufacturing processes including assembly, extrusion, and molding.Develop and sustain products in compliance with its Quality and Regulatory standards.Prepare and finalize reports, presentations, and project documentation.Assign project tasks within the team to meet milestones and objectives.Plan and execute Design Verification and Validation in line with ISO standards, CE norms, FDA, and its Quality Manual.Conduct Design Verification Testing using expertise in materials, fluid dynamics, and equipment applicability.Partner with the Project Management Office on project planning, budgets, timelines, and resource allocation.Present team progress and outcomes to stakeholders.Lead design activities with manufacturability in mind, ensuring smooth transfer to manufacturing. QualificationsBachelor's degree in Engineering (discipline flexible).5 8 years of experience leading or managing technical projects.Strong background in disposable medical devices (e.g., IV sets).Hands-on experience with manufacturing processes such as extrusion, molding, and assembly.Proven ability to manage multiple tasks, lead cross-functional teams, and deliver on milestones.Solid understanding of regulatory and quality standards in medical device development.