Senior Engineer

Thousand Oaks, CA 91320

Posted: 05/01/2024 Job Number: 39083

Job Description


Engineer Senior


Top 3 Must Have Skill Sets:
  • Experience performing data analysis using statistical software, (JMP, Minitab)
  • Experience modeling test fixtures, reference samples on solidworks or any other CAD software
  • Root cause analysis, CAPA deviation
  • Equipment method and test validation experience
  • Technical writing experience

Red Flags:
  • No engineering background.
  • No CAD background.
  • No troubleshooting and root cause investigation experience.
  • No data analysis experience.
  • No technical writing experience
  • Lack of experience working in technical team / team work

Summary:

The Senior Engineer is responsible for engineering activities required for development / qualification / validation and transfer of GMP physical test methods for combination products, devices, primary container, and secondary packaging components, as required. This individual shall have the ability to work on multiple projects at one time that may involve either new or changed product, process, tooling or equipment introduction to improve product quality and reliability.

Responsibilities:
  • Assure transfer of new combination product test methods to QC or manufacturing, by developing six sigma processes and compiling all required documentation.
  • Implement projects per Combination Product Operations (CPO) and company procedures to ensure projects are completed on schedule and within established budget.
  • Apply core engineering principles to develop physical test methods for medical device and combination product systems.
  • Perform data analysis to support method development, qualification, validation, and transfer
  • Provide expert support in the design or redesign of tools and/or equipment required for manufacturing processes.
  • Provide expert support for investigations as well as new processes development required to improve manufacturing operations. Improvements may be required for a variety of reasons (i.e. quality, reliability, new product introduction, cost saving).
  • Coordinate gauge and equipment development and delivery with selected contractors.
  • Ensure that qualification parameters are met for product assembly and performance requirements.
  • Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.
  • Generate procedures necessary to support department and new product equipment.
  • Provide expert training to individuals in the operation and maintenance of processes, gauges and equipment introduced to the manufacturing department (i.e. production operator, mechanics, process engineers).
  • Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams). Supervise work of support staff during development and manufacture of system.
  • Excellent communication (written and verbal) and organizational skills
  • Develops and maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project deliverables
  • Networks with manufacturing, quality and regulatory organizations both internal and external to our company
  • Facilitates robust horizontal communication to ensure all functions are aware of changes in deliverables and impacts to risk.
  • Proactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficiently
  • Integrates partner/vendor timelines with our timelines as appropriate

Basic Qualifications:
  • Doctorate Degree
OR
  • Master's Degree and 3 years of Engineering experience
OR
  • Bachelor's Degree and 5 years of Engineering experience
OR
  • Associate's degree and 10 years of Engineering experience
OR
  • High school diploma/GED and 12 years of Engineering experience.

Preferred Qualifications:
  • M.S. or Ph. D. in Mechanical, Aerospace, Mechatronics, Chemical or Biomedical engineering
  • Excellent written and verbal communication skills together with demonstrated ability to work in a highly matrixed team environment
  • Experience with managing technical teams, including setting priorities and leveling resources
  • Technical writing experience
  • Spanish language skills preferred
  • Experienced with SolidWorks (or other 3D-CAD software)
  • Familiar with equipment and software IOQ
  • Experience with process characterization, scale-up, technology transfer experience, pFMEAs and dFMEAs
  • Experience with change controls, deviations, CAPA
  • Experience with combination products and device regulatory requirements
  • Understanding of the six sigma process, utilizing Minitab (or other statistical software packages) to solve statistical problems
  • Work history with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing
  • Experience with machine controls (PLC, HMI) and vision systems

 

Pay range is $38 - $43 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.  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.

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About Thousand Oaks, CA

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.