Icon hamburger
Briefcase

Create Job Alert.

Enter your email below to save this search and receive job recommendations for similar positions.
Thank you. We'll send jobs matching these to
No Thanks
US
What job do you want?
Apply to this job.
Think you're the perfect candidate?
Apply Now
Thumsup

You’re being taken to an external site to apply.

Enter your email below to receive job recommendations for similar positions.

Do you want to sign in or apply as a guest?

Default5

Engineer

Spectraforce Technologies Inc Thousand Oaks, CA Full-Time
$83,200.00 - $140,000.00 / year
Apply Now

Create Job Alert.

Get similar jobs sent to your email

Job Title: Engineer Senior
Location: Thousand Oaks, CA 91320
Duration: 12 Months

Description:

Onsite M-F

Years of experience - 5-7 years
Currently working remotely, but then will move onsite once COVID situation is over.

Ideal candidate- Mechanical or Electro-mechanical degree. Strong understanding and experience in design controls, failure investigation. Medical device industry experience and regulated work environment experience. Must have at least 2 years current industry experience.

The Senior Device Engineer will participate in lifecycle management related to commercialized drug delivery devices. This includes technical operations support for contract manufacturing, failure investigation, leading and assessing design changes, develop test procedures, scale-up and global launch, supplier development, and continues improvement.

Scope includes mechanical and electro-mechanical delivery devices, such as fluid transfer devices, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical and electro-mechanical delivery devices are maintained. The Engineer will participate in cross functional teams, leading device design activities such as developing product enhancements, analytical failure analysis and implementing design solutions, assessment of proposed changes, product launches, and defending inspection and follow through of commitments.

The position is located in Thousand Oaks, CA and requires up to 10% domestic and international travel.


Top 3 Must Have Skill Sets:

  • Mechanical or Electro-mechanical degree is preferred
  • Strong understanding and experience in design controls, failure investigation (leading an investigation)
  • Medical device industry experience and regulated work environment experience        


Job Responsibilities:

·         Accountability of maintaining technical records within design history file associated with assigned products

·         Develop Test Method, generate and maintain design specification, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, etc.

·         Lead system level root cause investigation, coordinate design improvements with development partners, strategic planning and execution of design changes and improvements.

·         Works with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications

·         Develop and maintain Electromechanical devices including hardware and software.

·         Individual contributor with Leadership attributes to effectively represent device engineer within a large network/matrix organization

Basic Qualifications:

Doctorate Degree
OR
Master’s degree and 3 years of Engineering or Operations experience
OR
Bachelor’s degree and 5 years of Engineering or Operations experience

Preferred Qualifications:

·         Mechanical or Electro-mechanical degree is preferred

·         Medical device industry experience and regulated work environment experience

·         Background in developing and commercialization of medical devices and knowledge of manufacturing processes

·         Strong understanding and experience in design controls, failure investigation, initiating and bringing complex projects to conclusion and the ability to work independently and dynamic cross functional teams are required

·         Excellent written and verbal communication skills required.

·         Familiarity with the following standards and regulation:
o Quality System Regulation – 21CFR820
o Risk Management – ISO 14971
o EU Medical Device requirements – Council Directive 93/42/EEC



Recommended skills

Design Engineer
Engineering
Eumdr
Failure Analysis
Medical Device
Apply to this job.
Think you're the perfect candidate?
Apply Now

Help us improve CareerBuilder by providing feedback about this job: Report this job

Report this Job

Once a job has been reported, we will investigate it further. If you require a response, submit your question or concern to our Trust and Site Security Team

CAREERBUILDER TIP

For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.