Product Development Engineer

Job DescriptionResponsibilities: Applies state of the art techniques in the area of expertise to support the development of new or improved products Supports the sustainability and life cycle management of existing products Ensures compliance with global quality systems and Regulatory requirements related to product and process Provides Quality Assurance support and guidance for verification and validation of product requirements Performs design change control activities including impact assessments, reviews, and approvals Takes lead role in CAPA activities such as investigation, implementation, or verification of effectiveness Supports risk management activities as they relate to product and post market surveillance Interacts with on-shore and off-shore suppliers to complete project related activities Applies a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise toward the development of new or enhanced products Plans, executes, and works with minimal supervision and independent judgmentRequirements: Must have experience working with all classes of Medical devices preferably implantables, Biologics, and combination products with advanced training and demonstrate proficiency in problem solving, total quality management, DHF remediation, Risk file remediation, EUMDR, problem analysis and resolution, and design of experiments. Experience with new product development activities as R&D lead or QE lead in various product development teams. Demonstrates leadership skills to handle sustaining product support activities involving Complaint investigations, Trigger evaluations and Change controls. Extensive cross-functional team experience, including technical and non-technical work. Strong interpersonal, communication, influencing, and negotiation skills. B.S. degree in Engineering with at least 1-3 years of experience working in a regulated environment. Higher degrees desired with relevant experience in medical device industry. Demonstrated success in delivering results on several technical challenges. Working knowledge of medical device international standards.

Created: 2025-10-04