Senior Quality Engineer - Combination Products And Device Testing

NO C2C Eligibile

Senior Quality Engineer - Combination Products and Device TestingLocation: Thousand Oaks, CA Hybrid - ****************Monday, Wednesday, Friday (Remote) Tuesday, Thursday (On site) 8am - 5pm (flex) / 7am- 4pm********************
Duration: 12 months (Possible extension)

*******************CAPA and CAD**************************

Job 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 ***

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 *** 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.

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

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

Day to Day 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 ***

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 *** timelines as appropriate

Job Type: Contract

Pay: $60.00 - $68.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Education:

• Bachelor's (Required)

Ability to Relocate:

• Thousand Oaks, CA: Relocate before starting work (Required)

Work Location: In person