CenterMed, Inc. is a medical device startup based in the exciting bay area. CenterMed, Inc is determined and focused on developing patient-matched maxillofacial surgical accessories. We are looking for a R&D Engineer to join our CenterMed team.
ESSENTIAL DUTIES and RESPONSIBILITIES:
· Design, develop and optimize patient-matched products
· Generate work instructions, test methods, engineering models and drawings/prototypes to characterize product and process specifications
· Develop test strategy based on design requirements derived from voice of customer, and execute protocol, testing, data analysis, and reports required for regulatory submissions
· Identify issues, conduct root cause analysis, and map out resolution when designing parts, components and sub-assemblies using engineering first principles and appropriate test evaluations
· Create and update design control documents, including updating risk analysis documents, based upon technical knowledge of device and procedure
· Initiates new or revised documentation and tracks through appropriate approval cycles and implementation.
· Maintains a professional working relationship with internal and external customers and support staff.
· Provides technical support on components, material methods, systems and equipment.
· Create protocols and test methods.
· Coordinates/develops validation studies on equipment and processes.
· Understands and follows company procedures and regulatory requirements.
· Participates in and provides input to training on department and division procedures, and policies.
· Plans and coordinates engineering test builds.
· Analyzes problems in design, process and test development. Recommends solutions.
· Prepares and presents oral and written project updates and technical discussions.
Minimum Technical Qualifications:
· Bachelor’s degree in biomedical/bioengineering/mechanical engineering
· Basic tooling and design and drafting knowledge
· Basic product design & prototyping
· Comparative statistics
· Software application skills
· Strong problem solving ability
· Experience generating engineering proposals
· Oral and written presentation skills
· Understanding of regulatory and GMP environment
· Prior internship or co-op experience a plus
· 1-3 years of engineering experience within the medical device or equivalent industry.
· Familiarity with Additive Manufacturing methods
What we’re looking for:
· Ability to make and present engineering decisions.
· Strong interpersonal skills.
· Ability to analyze and optimize existing process and ability to create new processes
· Ability to create, critique and implement training
· Ability to create, analyze and optimize manufacturing and quality systems
· Experience creating, reviewing and coordinating test protocols and reports
· High level of proficiency in engineering and scientific principles
· Self-starter and driver – able to execute numerous tasks effectively
· Excellent communication skills, both written and verbal
· Flexible and adaptable, comfortable working in a dynamic environment