Quality Engineer - US Tech Solutions

Job Details:

Job Title: Engineer Senior

Duration: 12 months contract

Location: Thousand Oaks, CA 91320 (Onsite)

Pay Range: $40.00 to $45.00/hour on W2 without benefits

Shift: Mon to Fri 8:00 AM PST to 5:00 PM PST

Domain: Scientific/Manufacturing

Internal Job ID: 25-29544

Description:

• Lead teams in the development of drug delivery devices.
• Scope includes a wide range of devices, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems.
• The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices.
• The Senior Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices.
• The role of the Senior Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.

Responsibilities:

• Work cross-functionally with individuals and project teams in Marketing, Operations, and Development
• Create and assess product requirements to determine technical coverage and proper integration different subsystems.
• Create and execute to project plans and schedules
• Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
• Provide deep technical assistance for junior engineers.

Skills:

• BS in Engineering and previous experience in a medical device industry
• Experience with engineering processes and procedures.
• Strong background in engineering and commercialization of electro-mechanical medical devices.
• Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
• Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
• Experience in drug/device combination product design and development
• Small scale device assembly experience.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Strong problem solving, risk assessment, and risk management skills.
• Must be capable of working on multiple projects in a deadline driven environment.

Top 3 Must Have Skill Sets:

1. Previous experience in medical devices/pharma
2. Project management
3. Good Documentation Practices

Day to Day Responsibilities:

• Worker must be able to accomplish given tasks with minimal supervision.
• Expectation is that worker will lead projects to completion and work cross functionally to overcome any technical hurdles.

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

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Thanks and Regards,

Anmol Singh

Email: anmol.singh@ustechsolutionsinc.com

URL: www.ustechsolutions.com

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