Job Title - Senior Engineer
Location - Thousand Oaks, CA - 91320 Onsite
Duration: 12 Months
Description:
ONSITE USTO
Standard business hours
What you will do
Let's do this. Let's change the world. In this vital role you will perform Sustaining Engineering activities of combination products with electromechanical delivery systems. Such activities support the identification, review, assessment, and resolution of deficiencies throughout the product's life cycle. Responsible for product life cycle change management and ensures design controls are documented in accordance with internal procedures.
Office-based role supporting virtual teams via Webex and phone.
Flexibility required when working with global colleagues in various time zones.
Must be able to travel up to 5% - Would be to Phoeniz AZ if required
Key Responsibilities
Complete product and manufacturing process changes, including documentation and risk file updates to ensure there is no adverse impact to the patient/user and product design integrity is maintained
Implement change projects according to internal procedures, supervise progress, and communicate status to group leadership
Communicate with Engineering, Manufacturing, Regulatory, and Quality colleagues
Establish experimental protocols, conduct experiments, analyze results
Support technical execution of Design History File (DHF) updates
Establish and maintain relationships with manufacturing site colleagues
Support Manufacturing and Quality Assurance in the disposition of Non-Conforming Reports and the qualification of material/processes changes
Establish and review specifications/requirements for components, products and processes
Support CAPA investigations
Ensures product conforms to current relevant international standards
Support multi-functional assessment of complaint record
Preferred Qualifications
Bachelor's degree in Engineering, Science or other technical degree
1-3 years of experience with Medical Device or Combination Products Design Controls, Production, Sustaining Engineering, or Quality role
Proven knowledge and experience in Device Design Control, Risk Management, Medical Devices, and Combination Products
Experience analyzing patient/user impact
Understanding and practical knowledge of 21 CFR Part 820, ISO 13485 and ISO 14971 and relevant industry standards
Critical thinking, and problem-solving skills
An ability to work independently as well as a member of a team in a fast-paced environment
Working knowledge of statistical methods for data analysis
Familiar with microcontroller-based firmware, software verification (unit, static, dynamic
analysis)
Familiar with circuit design, analysis, troubleshooting, and testing, PCB/PCA assembly and fabrication
Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering fields
The position requires excellent organizational, technical problem solving and communication
skills (written and verbal) and the ability to lead external teams
Basic Qualifications
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
Top 3 Must Have Skill Sets:
? Medical device industry experience and regulated work environment experience
? Medical Device Design Controls experience
? Root cause analysis experience
Day to Day Responsibilities:
Complete product and manufacturing process changes, including documentation and risk file updates to ensure there is no adverse impact to the patient/user and product design integrity is maintained
Implement change projects according to internal procedures, supervise progress, and communicate status to group leadership
Communicate with Engineering, Manufacturing, Regulatory, and Quality colleagues
Establish experimental protocols, conduct experiments, analyze results
Support technical execution of Design History File (DHF) updates
Establish and maintain relationships with manufacturing site colleagues
Support Manufacturing and Quality Assurance in the disposition of Non-Conforming Reports and the qualification of material/processes changes
Establish and review specifications/requirements for components, products and processes
Support CAPA investigations
Ensures product conforms to current relevant international standards
Support multi-functional assessment of complaint record