Research and Development Engineer

Role Overview

The Research and Development Engineer 2 functions as a technical leader or emerging expert in their field, applying engineering principles to overcome technical challenges and ensuring medical products comply with clinical, safety, and quality standards.

Key Responsibilities

• Lead segments of projects or programs while supporting additional project teams as necessary.
• Collaborate across multiple functional departments, enhance technical expertise, and provide mentorship and leadership within their specialty.
• Help develop and refine best practices within focus work areas.
• Oversee technical development aspects for specified project portions.
• Guide critical design choices to ensure designs meet end-user needs.
• Achieve milestones within their technical domain.
• Work within project teams to define and agree on focus areas for projects across functional units.
• Conduct research to advance best practices in designated areas.
• Assist in creating procedural documentation or white papers to support functional groups.
• Ensure appropriate implementation of new methodologies and concepts.
• Engage with subject matter experts, clinicians, and product managers to innovate medical devices advancing patient care.
• Take responsibility for data interpretation and coordinate activities related to project sections.
• Develop and maintain design history files with accurate documentation.
• Support development and integration of new processes and improvements impacting department success metrics.
• Apply engineering expertise to aid department goals.
• Contribute to the company's intellectual property by offering technical inputs focused on innovation.
• Employ creative problem-solving to design next-generation medical devices, addressing complex engineering challenges and elevating product and process standards.
• Communicate and collaborate with cross-functional teams to facilitate achievement of project targets.
• Acquire knowledge of organizational business systems and procedures as relevant to responsibilities.

Requirements

• Bachelor’s degree in Engineering with at least 3 years of relevant professional experience. Advanced degrees such as Master’s or PhD can reduce required experience by two to four years.
• Proven experience in a technical role within the Medical Device field or a similarly regulated industry. Experience with vascular delivery systems, stents, or stent grafts is favorable.
• Minimum three years’ experience creating and managing Design History File documentation, including risk management, design inputs, standards, test protocols, and reports for Class III medical devices.
• Knowledge of sterilization, animal studies, microbiology, and biocompatibility is an advantage.
• Strong analytical reasoning and critical thinking capabilities.
• Excellent technical writing skills.
• Capability to collaborate across departments to solve complex problems effectively.
• Familiarity with applicable ISO, EU, and FDA medical device standards and regulations is preferred.
• Must be capable of fulfilling job duties considering reasonable accommodations aligned with local and national laws.

Work Environment and Conditions

• Work performed mainly in an office environment.
• Extended sitting periods and tasks requiring significant visual focus on computers.
• Personal protective equipment may be required in specific work areas per health and safety standards.
• Occasional travel may be necessary.