Crystal Equation
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Engineer
Top 3 Must Have Skill Sets:
Red Flags:
Missing two or more of the following four items:
Additional stand-alone red flag: inability to be present on site/support ATO-site based activities. This is a hybrid role, NOT fully remote.
Summary:
The Device Engineer will play a critical role in the design, development, and lifecycle management of drug delivery devices, including prefilled syringes, with a focus on testing and analysis within a laboratory environment. This position requires strong experimental, analytical, and statistical skills to support technical operations and ensure the success of our combination product portfolio.
Day to Day:
Key Responsibilities:
The ideal candidate will:
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. 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. 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.
Device Engineer
1 Amgen Center Dr. Thousand Oaks, CA 91320 US
Posted: 01/08/2025
2025-01-08
2025-02-13
Job Number: 40095
Job Description
Engineer
Top 3 Must Have Skill Sets:
- Problem solving (engineering skillset)
- Organization (self-starter and project level management)
- Communication (experience communicating at different levels and to different groups)
Red Flags:
Missing two or more of the following four items:
- Degree in the field of Mechanical or Biomedical.
- Medical device industry and/or regulated work environment experience.
- Excellent written and verbal communication skill.
- Understanding and experience in:
- Development/commercialization of medical devices and knowledge of manufacturing processes
- Initiating and bringing complex projects to conclusion
- Ability to work independently and dynamic cross functional teams
- Design controls
- Failure investigation
- Applied statistics
Additional stand-alone red flag: inability to be present on site/support ATO-site based activities. This is a hybrid role, NOT fully remote.
Summary:
The Device Engineer will play a critical role in the design, development, and lifecycle management of drug delivery devices, including prefilled syringes, with a focus on testing and analysis within a laboratory environment. This position requires strong experimental, analytical, and statistical skills to support technical operations and ensure the success of our combination product portfolio.
Day to Day:
- Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.
- Plans and conducts work requiring judgment in the independent evaluation, selection, and adaptation and modification of standard techniques/procedures/criteria, and devises new approaches to encountered challenges.
- Generates and maintains design specifications, protocol and report writing, prototyping, design of experiments/statistical process control product optimization, design verification & validation, FMEA, etc.
- System level root cause investigation
- Coordinate and implement design improvements with development partners.
- Collaborate with scientists and engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
- Accountability of maintaining technical records within product design history files.
- Individual contributor with leadership attributes to effectively represent device engineering within a large network/matrix organization.
- Working proficiency and familiarity with governing standards and regulations, including Quality System Regulation (21CFR820) and Risk Management (ISO 14971).
Key Responsibilities:
- Conducting hands-on experimental testing to support failure investigations and root cause analysis.
- Developing, executing, and refining test procedures to evaluate device performance and functionality.
- Analyzing test data and applying statistical methods to derive actionable insights and recommendations.
- Supporting design changes by leading testing efforts to assess and validate proposed modifications.
- Participating in the scale-up, global launch, and continuous improvement of drug delivery devices.
- Collaborating with contract manufacturers and suppliers to ensure device quality and performance standards are met.
- Maintaining robust design history files for mechanical and electro-mechanical delivery devices.
- Enhancing and expanding our delivery device platform as needed to meet evolving product and regulatory requirements.
The ideal candidate will:
- Have strong laboratory testing experience, particularly with combination products and medical devices.
- Possess a solid foundation in experimental methods and data analysis.
- Be proficient in statistical tools and methodologies.
- Demonstrate experience in failure analysis and implementing design solutions.
- Have a proven ability to collaborate effectively within cross-functional teams.
- Exhibit strong organizational skills and attention to detail, especially in maintaining design history files.
- Show familiarity with regulatory and quality requirements for combination products and medical devices.
- This role offers the opportunity to make a meaningful impact by leveraging technical expertise in a dynamic and innovative environment focused on advancing our portfolio of drug delivery devices.
- 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
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. 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. 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.