Design Quality Engineer - ICONMA, LLC
Cupertino, CA 95014
About the Job
Our Client, a Consumer Products and Software Services company, is looking for a Design Quality Engineer for their Cupertino, CA/Hybrid location.
Responsibilities:
Requirements:
Why Should You Apply?
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.
Responsibilities:
- Ensuring that Design Controls are properly executed in accordance to established standard operating procedures
- Leading risk management activities in relation to design changes, and issues discovered during internal testing, and in the field
- Completing and supporting design change assessments and completing design control documentation to support new software releases
- Identifying and implementing effective systems to support products post market
- Implementing the execution of systems which identify and resolve quality issues (CAPAs)
- Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
- Implementing various product and process improvement methodologies
- Working with the teams on investigation, resolution and prevention of product and process non-conformances
- Complying with applicable regulatory requirements, procedures, and processes, requirements
Requirements:
- 3+ years of medical device experience in a quality/regulatory role
- Familiarity with 21 CFR 820, ISO13485, ISO 14971, IEC 62366, IEC 62304 and other applicable regulations
- Experience interpreting requirements and following standard operating procedures
- Experience with design control, and risk management activities for medical devices, including development and maintenance of design history files
- Exceptional organizational and management skills
- Excellent interpersonal skills, both verbal and written
- B.S. ME/EE/BME/CS degree or equivalent in any engineering/science discipline
- Additional Requirements: Experience in working on software as a medical device (SaMD) products
Why Should You Apply?
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.
Source : ICONMA, LLC
