R&D Product Engineer II
MedTechPharmaQuality Assuranceheoremafdaiso 13485croinform
Job description
We anticipate the application window for this opening will close on - 30 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Careers that Change Lives As part of the Surgical Released Product Engineering (RPE) Team, we drive best in class clinical outcomes, customer satisfaction and business value for all commercialized Surgical products by ensuring consistent quality, supply continuity and market competitiveness while elevating the technical careers of employees. The R&D Product Engineer II will report into the Wound Management (WM) RPE Team within the WM Center of Excellence (COE) group of R&D. They will focus on supporting changes to existing products to meet customer needs and maintain our wound management product lines. They will serve as the design owner and technical expert, supporting released product engineering teams by planning, developing, and executing design changes, testing and analysis activities during product change implementation. This role focuses on driving improvements in product performance and manufacturability, reducing cost, improving quality and ensuring supply continuity while maintaining design intent. Specifically, the R&D Product Engineer II will focus on mechanical design and packaging design relating to absorbable medical devices, inside the sterile barrier. A Day in the Life Designs, develops, analyzes, troubleshoots, and provides technical support during product development and manufacturing. Works independently under general supervision to determine and develop approach to solutions Designs studies to investigate root cause or identify process parameters. Updates engineering drawings and specifications with CAD software; conducts tolerance stacks and evaluations of design changes. Proposes design improvements to components or products to improve quality, cost, or manufacturability Provides design input for changes and new tooling of injection molded components Involved in activities to support product development, improvements to existing products and pre-clinical studies. Defines and performs verification and validation activities ensuring products meet user needs and intended use. Guides the conceptualization of new methodologies, materials, machines, or processes related to existing product manufacturing and design. Coordinates activities with outside suppliers and consultants to ensure timely delivery. Writes engineering reports and creates presentations as required to document and communicate results. Collaborate with peers to manage the development of appropriate testing to verify product meets internal and external customer requirements. Supports technical evaluations for OEM, BD&L, and commercial driven evaluations with a focus on design ownership Conducts design analysis of customer complaints and returned products, partnering with Design Quality and Manufacturing to identify root cause and implement corrective actions Partners cross-functionally with Design Quality Engineering, Manufacturing Engineering, Plant Quality Engineering, Operations, and Supply Chain Minimum Requirements: Bachelor’s degree in Engineering (Biomedical, Mechanical, Materials, Manufacturing, or related engineering discipline required). Bachelors degree in Engineering, plus 2 years relevant work experience, OR a Master’s degree in Engineering, with 0-2 years work experience. Preferred Qualifications: Experience supporting medical devices, particularly wound management and absorbable medical products. Hands-on experience with product packaging design, inside of sterile barrier. Experience with medical device product and component mechanical design through CAD programs, tolerance stacks, and analytical modeling. Experience with injection molded components and tooling Hands-on experience with root cause analysis, design verification, design validation, and supplier collaboration. Familiarity with ISO 13485, FDA Quality System Regulations, and design control/change management processes. Experience analyzing customer complaints, product returns, or field issues. Strong communication skills with the ability to work effectively across technical and non-technical teams. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable a
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