Thousand Oaks, CA 91320

Posted: 03/14/2023 Job Number: 37145

Job Description

Pay range is $30 - $37 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.

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.



Top 3 Must Have Skill Sets:    
  • Hands on Laboratory Experience in a GLP Setting- 1+ years of experience
  • Good Communication and Technical Writing Skills
  • Ability to Multitask
  • Must have BS degree Mechanical or Biomedical Engineering, or related field

Red Flags:    
  1. No laboratory experience or desire to work in a lab environment (not considering less than a year)
  2. No desire to work in cross-functional team environment
  3. Poor communication and technical writing skills
  4. Many positions in a short time frame (e.g. 3 per year)
  5. Interested in remote-only; this job requires on-site attendance

Day to Day:

The Device Engineer will participate in the medical device/combination product design, development, and commercialization activities for drug delivery devices, focusing on prefilled syringes.

Key responsibilities include:
  • Test procedure development and functional test execution
  • Authoring technical plans and reports
  • Performing statistical data analysis
  • Supporting technical assessments and root cause investigations
  • Transfer of information to manufacturing sites, engagement with suppliers
  • Maintenance of Design History File content consistent with Good Documentation Practices

Essential Skills:
  • 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; CAD/SolidWorks proficiency; tolerance analysis; capability analysis.
  • 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).

Preferred Qualifications:
  • Degree in the field of Mechanical or Biomedical Engineering, or related field
  • 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

Meet Your Recruiter

Scott Brasel

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