Crystal Equation
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Engineer
Top 3 Must Have Skill Sets:
Summary:
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. Support multi-functional assessment of complaint records.
Responsibilities:
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Pay range is $31 - $36 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
THE PROMISES WE MAKE:
At Crystal Equation, we empower people and advance technology initiatives by building trust. Â Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. Â We will serve to empower you along the way and provide the path for your professional journey.
For more information regarding our Privacy Policy, please visit crystalequation.com/privacy.
Engineer
1 Amgen Center Dr. Thousand Oaks, CA 91320 US
Posted: 11/21/2024
2024-11-21
2025-01-12
Job Number: 39960
Job Description
Engineer
Top 3 Must Have Skill Sets:
- Ability to clearly communicate with diverse teams, including Engineering, Manufacturing, Regulatory, and Quality colleagues.
- Strong written skills for documenting changes, updates to risk files, and communication with leadership.
- Multidisciplinary assessment of complaints and problem-solving.
- Difficulty clearly communicating with cross-functional teams or documenting changes effectively.
- Lack of precision or detail in written documentation
- Inability to convey project progress or results to leadership, leading to misunderstandings or misalignment.
Summary:
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. Support multi-functional assessment of complaint records.
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 manufactuing 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
- Master degree
- Bachelor degree and 2 years of experience
- Associate degree and 6 years of experience
- High school diploma / GED and 8 years of experience
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Pay range is $31 - $36 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
THE PROMISES WE MAKE:
At Crystal Equation, we empower people and advance technology initiatives by building trust. Â Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. Â We will serve to empower you along the way and provide the path for your professional journey.
For more information regarding our Privacy Policy, please visit crystalequation.com/privacy.
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Ready to take your career to the next level in the vibrant city of Thousand Oaks, California? Nestled in the heart of Ventura County, this bustling city offers a perfect blend of suburban charm and urban amenities. With a strong job market, top-notch schools, and breathtaking views of the Santa Monica Mountains, Thousand Oaks is an ideal location for professionals seeking growth and fulfillment. Explore job opportunities near iconic sites like the Gardens of the World, catch a show at the Fred Kavli Theatre, or indulge in the local culinary scene featuring dishes from around the world. Join this dynamic community and unlock your potential in Thousand Oaks! Start your job search now to find your perfect fit in this captivating city.