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Crystal Equation
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Engineer
Top 3 Must Have Skill Sets:
Red Flags:
Summary:
The Device Engineer will participate in the design, development, and lifecycle management design control activities for commercialized drug delivery devices. This role includes technical operations support for combination product development to global launch, clinical and commercial manufacturing, failure investigation, design change evaluation, development and execution of test procedures, and continuous improvement initiatives.
Scope includes mechanical delivery devices, such as; Prefilled syringes. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as the development of product enhancements, analytical failure analysis and implementation of design solutions, assessment of proposed changes, support product launches, defend inspection and ensure the follow through of commitments.
The device engineer will support a senior engineer on a variety of projects related to laboratory testing, life cycle management, and product-based initiatives regarding prefilled syringes in both the commercial and developmental space. The engineer will be expected to author protocols, reports, and further technical documentation while adhering to GMP standards. Laboratory testing will primarily include the use of an Instron force tester and vision systems. The identified candidate must be able to lift up to 50 lbs for receipt and transferring of material. Fill-Finish experience is a bonus but not mandatory.
Engineer will be evaluated on ability to complete a wide variety of supporting tasks for projects in a timely manner while maintaining a high standard of quality.
Responsibilities:
Basic Qualifications:
OR
OR
OR
Preferred Qualifications:
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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: 11/20/2024
2024-11-20
2025-01-08
Job Number: 39952
Job Description
Engineer
Top 3 Must Have Skill Sets:
- Authors and reviews technical documentation including protocols, reports, and technical assessments
- Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
- Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments, plans and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devises new approaches to problems encountered.
Red Flags:
- Lack of hands-on experience in engineering or a translatable field like farming or factory work.
- Poor communication or teamwork skills, especially for candidates with no collaborative experience.
- Unwillingness to relocate or commute daily to ATO for this on-site role.
- Weak technical writing skills.
- Reliance solely on theoretical or textbook knowledge without practical application.
- No experience in relevant industries, such as medical device manufacturing, biopharma, or packaging.
- 4.0 GPA
- PhDs or Masters candidates that have over 3 Years of experience
Summary:
The Device Engineer will participate in the design, development, and lifecycle management design control activities for commercialized drug delivery devices. This role includes technical operations support for combination product development to global launch, clinical and commercial manufacturing, failure investigation, design change evaluation, development and execution of test procedures, and continuous improvement initiatives.
Scope includes mechanical delivery devices, such as; Prefilled syringes. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as the development of product enhancements, analytical failure analysis and implementation of design solutions, assessment of proposed changes, support product launches, defend inspection and ensure the follow through of commitments.
The device engineer will support a senior engineer on a variety of projects related to laboratory testing, life cycle management, and product-based initiatives regarding prefilled syringes in both the commercial and developmental space. The engineer will be expected to author protocols, reports, and further technical documentation while adhering to GMP standards. Laboratory testing will primarily include the use of an Instron force tester and vision systems. The identified candidate must be able to lift up to 50 lbs for receipt and transferring of material. Fill-Finish experience is a bonus but not mandatory.
Engineer will be evaluated on ability to complete a wide variety of supporting tasks for projects in a timely manner while maintaining a high standard of quality.
Responsibilities:
- Adheres to strict documentation practices in a GMP regulated environment
- Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments, plans and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devises new approaches to problems encountered.
- Authors and reviews technical documentation including protocols, reports, and technical assessments
- Analyze and trend generated data by applying relevant statistical techniques to enable senior staff to make informed decisions
- Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
- Maintains combination product design history files for assigned products
- Develops characterization test methods through fixture prototyping, reference sample creation, and GR&R analysis
- Provides functional subject matter expertise to actively participate in cross-functional activities including system level root cause analysis, design changes, and change control assessments
- Provide general laboratory support including inventory management, sample shipments, and cleanup.
- Works with Scientists and Engineers, to assess and develop appropriate design and manufacturing specifications
- Individual contributor with Leadership attributes to effectively represent device engineer within a large network/matrix organization
- At a minimum familiar with the following standards and regulations:
- Quality System Regulation – 21CFR820
- Risk Management – ISO 14971
- EU Medical Device requirements – Council Directive 93/42/EEC
Basic Qualifications:
- Master degree
OR
- Bachelor degree and 2 years of experience
OR
- Associate degree and 6 years of experience
OR
- High school diploma / GED and 8 years of experience
Preferred Qualifications:
- Bachelor’s Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
- Minimum 2 year of scientific or engineering experience in a GMP regulated environment
- Statistical Analysis software (Minitab or JMP)
- Strong technical writing skills
- CAD fixturing software (SolidWorks)
- Instron force tester using BlueHill Universal
- Experience with design controls; including (but not limited to) verification and design transfer
- Understanding of risk assessments including hazard and probability analysis
- Background in medical device development, commercialization and knowledge of manufacturing processes (fill-finish)
- Ability to work independently and dynamically across functional teams
- Excellent written and verbal communication skills
- Ability to support complex workstreams under demanding timelines
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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.