Engineer Senior, Combination Device Life Cycle Change Management

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

Location : Thousand Oaks, Ca.

Business Unit : Final Product Technologies Commercial Advancement

Employment Type : Contract

Duration : 1+ years with possible extensions or conversion to FTE

Rate : $45 - $50 / hour W2

Posting Date : 11 / 10 / 2023

Note : Office-based role supporting virtual teams via Webex and phone.

3 Key Consulting is recruiting an Engineer Senior, Drug Delivery Medical Devices for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description :

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 .
• What we expect of you :

We are all different, yet we all use our unique contributions to serve patients. The technical professional we seek is a collaborative partner with these qualifications.

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

Preferred Qualifications

Top Must Have Skill Sets :

Why is the Position Open?

Supplement additional workload on team

Red Flags :

Poor verbal communication skills

Interview Process :

Phone Interview followed by WebEx meeting / panel interview

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com . If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com / careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Regards,

3KC Talent Acquisition Team