Irvine, CA On-site

Full-time · Entry level
201-500 employees · Medical Equipment Manufacturing

Essential Functions And Main Duties

Possess a software development experience
Able to effectively translate Quality standard regs in a manner that is efficient for product development.
Create and execute test protocols.
Regulated Quality experience.
Create procedures to support IEC 62304, SIO 13485 and ISO 14971
Audit SOP’s for compliance.
Prepare metric and status information on the complaint handling program as required
Assist as needed in the preparation of data for internal audits and external audits/inspections
Adhere to all company policies, procedures, and business ethics codes.
Duties may be modified or assigned at any time based on business need.

Qualifications

Education / Certification / Experience required:

Bachelor’s degree in engineering or related discipline; relevant education and experience accepted in lieu of degree
5-8 years of experience in software development
General knowledge and application of engineering concepts required
Familiarity with medical device regulatory requirements a plus

Competencies Required

Knowledge of Agile software development process
Problem solving skills
Communication skills
Analytical ability
Ability to multi-task
Able to work effectively both independently and in a collaborative team environment