R&D Engineer

Dentsply Sirona, Inc • West Manchester Township, PA

7d

About The Position

As a R&D Engineer, this role is responsible for the design, development, integration, and lifecycle support of electromechanical medical devices and subsystems in a U.S. FDA-regulated environment. The position combines strong hands-on engineering expertise with deep practical experience operating under FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and applicable U.S. and international standards.

This role works closely with Quality Assurance, Regulatory Affairs, Manufacturing, Clinical, and Supply Chain teams to ensure products are developed in full compliance with FDA Design Controls and are inspection-ready at all times, supporting 510(k), De Novo, or PMA submissions.

Requirements

• Bachelor’s or Master’s degree in Mechanical Engineering, Electromechanical Engineering, Mechatronics, or related discipline.
• Minimum of 5 years of experience developing electromechanical products under stringent safety, quality and regulatory requirements
• Significant experience in a U.S. FDA-regulated medical device environment.
• Strong electromechanical system design and integration skills.
• In-depth knowledge of FDA QSR, ISO 13485, and ISO 14971 risk management.
• Experience with verification and validation activities.
• Ability to specify prioritized technical requirements based on expectations and regulatory constraints. Ability to clearly document and defend technical decisions during FDA inspections and audits.
• Advanced knowledge of MS Office, including but not limited to, Word, Excel, PowerPoint, and Outlook
• Experience with computer-aided engineering (CAE) tools for mechanical and electrical design.
• Ability to work flexibly and handle multiple projects under tight deadlines while maintaining operational excellence
• Ability to build strong relationships and work across global internal and external teams across multiple geographies, cultures and time zones
• Fluent in English (reading, writing and comprehension)

Nice To Haves

• additional languages considered a plus
• May require domestic and international travel

Responsibilities

• Lead the design and development of electromechanical systems, components, and assemblies for medical devices
• Translate user needs and system requirements into robust technical solutions with full design traceability.
• Execute development activities in compliance with FDA 21 CFR Part 820 and ISO 13485.
• Author and maintain inspection-ready Design History Files (DHF).
• Support regulatory submissions and FDA inspections.
• Support design transfer to manufacturing including DFM/DFA and DMR/DHR documentation.
• Participate in CAPA, complaint handling, and root cause investigations.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees