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Posted: 04/12/2024 Job Number: 38978

Job Description

Engineer

Top 3 Must Have Skill Sets:

Detail-oriented
Works well in teams
Education or experience related to working in a regulated industry (i.e. Medical, Aerospace, etc.)

Red Flags:

Cannot be fully remote, requires ~50% onsite work
Needs strong communication skills

Description:

This is going to be a Thousand Oaks role and the EW will be working in several different buildings. At least 50% onsite for this role and this requirement will vary based on workload. Mon-Fri 8 AM - 5 PM. Need candidates that are local to the office.
Hiring Manager is ideally looking for candidates with a scientific background or engineering. Ideal candidate will have a background in a Biomedical, Chemical engineering or mechanical engineering.
Would be a plus if the candidates have experience regulated industry experience, biotech and pharma.

**Both interviews will be virtual.**

Summary:

This position reports into the Combination Product Operations Development and Lifecyle Management group in Thousand Oaks, CA, supporting senior staff in design, characterization, and qualification of combination products. This position requires the application of engineering principles to perform the job functions and the ability to coordinate and communicate effectively across different functions to successfully complete projects.

Requirements:

Plan and author technical documentation, including test plans/protocols/reports and a variety of engineering assessments.
Perform hands on testing of autoinjector devices, including the safe operation of test equipment and devices containing sharps (syringes).
Analyze and report data, along with any recommendations, to a variety of stakeholders.
Provide technical input for mechanical problems to programs as needed.
Plan and execute tolerance and robustness analysis of complex mechanical designs.
Use project planning and monitoring methods to ensure accurate completion.
Collaborate with cross-functional teams to ensure adequate sustainment and improvement of products throughout their lifecycle.
As part of the team working on device platforms, ensure alignment to architecture to support variations of the platform and system deliverable packages.

Basic Qualifications

B.S. in Engineering or Scientific Discipline
Effective Communicator (Oral/Written)
Technical Writing (Protocols, Reports, Technical Assessments, Presentations)

Preferred/Demonstrated Competencies:

Broad set of knowledge and expertise in contributing to complex, multi-disciplinary and cross-functional product development efforts
Experience in drug/device combination product design, and development
Background in development, commercialization, and lifecycle management of medical devices
Physical test method development, qualification, and validation
Experience executing lab tests, including safe and proper operation of lab equipment (Instron tensile tester, Keyence inspection equipment, etc.)
Experience conceptualizing, designing, and building test fixtures
Technical understanding of drawings including tolerance stacks and robustness analysis
Knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position
Familiarity with the following standards: US Good Manufacturing Practices (21CFR820), Quality Management (ISO 13485), Risk Management (ISO 14971), EU Medical Device requirements (Council Directive 93/42/EEC), Needle Based Injection Systems (EN ISO 11608-1), and Medical Electrical Equipment (EN 60601)
Knowledge of dFMEA/pFMEA
Capable of working on multiple projects in a deadline driven environment
Strong oral and written communication skills, decision making, presentation, and organization skills
Ability to collaborate and converse technically with diverse partners such as hardware, software, systems, human factors, materials science, quality, reliability engineering, domain experts from commercial, clinical, molecular research, medical sciences, regulatory, drug substance and drug product development organizations
Demonstrate ability to navigate ambiguity and provide a structured problem-solving approach
Track record of building or participating as a member of successful teams
Working knowledge of MS Office tools

Pay range is $31 - $36 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.

Meet Your Recruiter

Krista McIlwaine

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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.