Engineer
Belcan
Job Title: Device Engineer
Location: Thousand Oaks, CA
Zip Code: 91320
Start Date: Right Away
Job Type: Contract- 12 months
Pay Rate: $35.7 /hr
Keywords: #DeviceEgineerJobs #HybridJobs
JOB DESCRIPTION
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.
JOB 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 delivery device platform as needed to meet evolving product and regulatory requirements.
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).
REQUIRED QUALIFICATIONS:
* Master or Bachelor's degree in the field of Mechanical or Biomedical.
* 2 years of related experience
* Medical device industry and/or regulated work environment experience.
* 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.
* Strong organizational skills and attention to detail, especially in maintaining design history files.
* Familiarity with regulatory and quality requirements for combination products and medical devices.
* Problem solving (engineering skillset)
* Excellent written and verbal communication skills and experience communicating at different levels and to different groups.
* 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
If you are interested in this role, please apply via the apply now link provided. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract, temporary, temp-to-hire, and direct assignments. We are the employer of choice for thousands worldwide. For more information, please visit our website at Belcan.com
EOE/F/M/Disability/Veterans
Location: Thousand Oaks, CA
Zip Code: 91320
Start Date: Right Away
Job Type: Contract- 12 months
Pay Rate: $35.7 /hr
Keywords: #DeviceEgineerJobs #HybridJobs
JOB DESCRIPTION
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.
JOB 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 delivery device platform as needed to meet evolving product and regulatory requirements.
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).
REQUIRED QUALIFICATIONS:
* Master or Bachelor's degree in the field of Mechanical or Biomedical.
* 2 years of related experience
* Medical device industry and/or regulated work environment experience.
* 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.
* Strong organizational skills and attention to detail, especially in maintaining design history files.
* Familiarity with regulatory and quality requirements for combination products and medical devices.
* Problem solving (engineering skillset)
* Excellent written and verbal communication skills and experience communicating at different levels and to different groups.
* 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
If you are interested in this role, please apply via the apply now link provided. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract, temporary, temp-to-hire, and direct assignments. We are the employer of choice for thousands worldwide. For more information, please visit our website at Belcan.com
EOE/F/M/Disability/Veterans
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