Website Intent Solutions, Inc.
Advancing Take as Directed
Intent Solutions™ is a technology-enabled services company focused on monitoring and managing medication adherence in clinical research and applied healthcare sectors. We are looking for an Engineering Manager, Medical Devices to join our growing company. This position supports product development activities through the design, development, and manufacture of mechanical and electromechanical medical device systems.
Apply engineering principles, analytical skills, and empirical methods to develop innovative product designs.
Assist in test planning and development to ensure device systems conform to specified customer requirements.
Manage contract engineering and manufacturing partners.
Complete assignments within established schedules and budgets.
REQUIRED KNOWLEDGE & SKILLS
Skilled in IoT electromechanical devices and injection molded components
Hands-on experience effectively resolving design, manufacturing, and vendor issues associated with tightly specified parts, component variability, and obsolescence
Good organizational, planning and time management skills.
Proficiency in Microsoft Office or Google for business.
Basic understanding of 510K & regulatory requirements for FDA-cleared Class II devices
Strong problem solving and analysis skills
Excellent communication skills both oral and written
Familiarity with QMS and/or ERP systems
Bachelor’s Degree in biomedical engineering, mechanical engineering, or a related discipline
Minimum 3 years experience in the medical device industry
Proven R&D experience with Class I & Class II medical devices
To apply for this job please visit app.trinethire.com.