Product Development Specialist - Medical Devices

About the Role

The R&D Engineer II will be responsible for designing, developing, and validating medical devices, working closely with cross-functional teams to ensure timely delivery of high-quality products.

Main Responsibilities:

• Design and development of medical devices, including catheters, in accordance with FDA regulations and company quality standards.
• Creation of technical documentation, including manufacturing instructions, test methods, drawings, BOMs, protocols, and reports to support design control activities.
• Verification and validation of medical devices, including testing and evaluation of prototype designs.
• Collaboration with engineers and QA to create new components, assemblies, or tools.
• Identification of hazards and mitigation of risk associated with identified hazards in Design and Process FMEA.
• Compilation and analysis of data, identification of causes, drawing of conclusions, and generation of reports.
• Providing hands-on, technical execution in the prototyping and development of devices.
• Management of processes and ensuring that activity goals are achieved.
• Training and/or providing work direction to technicians and less experienced engineers.
• Support for the development of specifications for tooling and fixturing according to company quality standards.

Key Qualifications:

• Engineering degree desired or equivalent experience in a related job field.
• At least 2 years of biomedical product or medical device development experience (catheter experience desirable).
• Working knowledge of mechanical design principles and FDA-regulated medical device design controls a plus.
• Proficiency in CAD software, preferably SolidWorks.
• Familiarity with statistical analysis of raw data is required, proficiency in Minitab preferred.
• Understanding of IEC60601 requirements/constraints for mechanical system design preferred.
• Experience managing suppliers and/or contract manufacturers a plus.
• Hands-on mechanical prototyping, verification, and failure analysis skills.
• Familiarity with design control according to 21 CFR 820 or ISO 13485, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA) preferred.

Skill Requirements:

• Proficiency in Risk Management according to ISO 14971.
• Knowledge of ASME Y14.5 GD&T.
• Excellent interpersonal, communication, and documentation skills required.
• Proven self-starter who runs towards critical issues, ambiguous requirements, or loosely defined challenges with a demonstrated ability to rally teams to achieve business results.
• Takes initiative and acts quickly to drive solutions.
• Strong interpersonal, organizational, and communication skills.
• A flexible team player, focusing on shared goals with a positive results-oriented attitude.

Bolt Medical Career Growth

We offer opportunities for career growth and professional development, including training and education programs, mentorship, and internal promotions.