Engineer Senior, Combination Device Life Cycle Change Management (JP11969)

3 Key Consulting•Thousand Oaks, CA

1d•Onsite

About The Position

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

Requirements

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
Medical device industry experience and regulated work environment experience
Medical Device Design Controls experience
Root cause analysis experience

Nice To Haves

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

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