Job Description

Title: Senior Engineer

Location : Thousand Oaks CA 91320

Duration : 12 months; possible extension

Description :

Onsite Thousand Oaks, CA - 2-3 days per week onsite.

B.S. and a minimum of 3+ strong years of experience. 5 YOE is ideal.

Nice to have: someone who has experience working on prefilled syringes or vials. Combination product experience. Regulatory experience.

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:

• Leading test procedure development and functional test execution

• Leading material inventory management for prefilled syringe programs, including material forecasting and material custody across multiple sites and functional groups.

• Authoring technical plans and reports

• Performing advanced statistical data analysis

• Supporting Leading technical assessments and root cause investigations as well as planning and delegation of sub-tasks to other team members.

• Transfer of information to manufacturing sites, engagement with suppliers

• Maintenance of Design History File content consistent with Good Documentation Practices

• Training junior staff on physical test methods, sample preparation protocols and procedures, and effective report writing.

• Reviewing primary data collected from peers in support for various design controls activities, including characterization and design verification.

• Supporting design transfer activities by leading cross-functional coordination of sample procurement and testing.

• Supporting the setting of specification limits for platform devices through human factors studies benchtop testing.

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

Basic Qualifications

Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience

Top 3 Must Have Skill Sets:

1. Pharma background.

2. Physical testing experience

3. Design controls experience

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