Sr. Product Development Engineer (Medical Devices)

Location: Carpinteria, CA, United States

Company

hirify.global develops and manufactures medical devices and related products under applicable regulatory and quality standards.

What you will do

• Lead multiple cross-functional medical device development projects and provide technical leadership throughout the product lifecycle.
• Translate customer and user needs into design requirements, specifications, prototypes, and technical documentation.
• Lead risk management, design reviews, process characterization, design verification, test method development, and fixture design.
• Collaborate with customers, clinicians, marketing, regulatory, quality, manufacturing, suppliers, and external experts to develop manufacturable and clinically relevant devices.
• Support design and process changes, product launches, audits, compliance activities, intellectual property work, and continuous improvement.
• Train and mentor junior staff and contribute to business development activities.

Requirements

• Bachelor’s degree in engineering, such as mechanical or biomedical engineering, or a related technical or scientific field.
• 8+ years of engineering experience in the medical device industry or a related field.
• Extensive knowledge of medical device standards, regulations, GMP principles, global regulatory requirements, risk assessment, and mitigation.
• Experience with customer or clinical studies, rapid prototyping, design for manufacturability, process characterization, biocompatibility, materials selection, and human factors engineering.
• Strong project management experience, including project planning, budgeting, meeting facilitation, and project management tools such as MS Project.
• Ability to lead cross-functional teams, manage design control processes, create technical documentation, communicate complex technical topics, and work independently in a fast-paced environment.

Nice to have

• Experience with 3D solid modeling and technical drawings for medical devices.
• Knowledge of intellectual property laws and practices, including patent applications and protection of proprietary technologies.

Culture & Benefits

• Full-time employment with an equal opportunity and diversity-focused employer.
• Work alongside customers, clinicians, suppliers, and multidisciplinary internal teams.