Sep 01, 2021

Research And Development Engineer

$60,000 - $80,000 yearly
  • CenterMed
  • Remote (Walnut Creek, CA, USA)
Full time Engineering R&D

Job Description

Job description

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


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