Job Title: Engineer Senior
Location: Thousand Oaks, CA 91320
Duration: 12 Months
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
· 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
Master’s degree and 3 years of Engineering or Operations experience
Bachelor’s degree and 5 years of Engineering or Operations experience
· 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