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Engineer 2

Company: Pioneer Data Systems
Location: Irvine
Posted on: January 26, 2023

Job Description:

Position Details:
Our client, a world-leading Pharmaceutical Company in Irvine, CA is currently looking for a Manufacturing Quality Engineer / Medical Devices / Hybrid Schedule to join their expanding team.

Job Title: Manufacturing Quality Engineer / Medical Devices / Hybrid Schedule
Duration: 12 months contract, extendable up to 24 months
Location: Irvine, CA
Hybrid work schedule - 2/3 days onsite.

The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan

Job Description:
Hybrid work schedule - 2/3 days onsite.

Work location:
IRVINE / CA / 92618

Key skill set manager is looking for is the engineer will have an mechanical engineering or equivalent degree. work hours 8 /day

In this role, the Engineer, will provide Quality Engineering Leadership and technical know-how in the development of product life-cycle improvements aimed at improving the Customer Experience.
This position will be accountable for the delivery of engineering solutions that improve the Customer Experience for JJSV products and equipment. In addition to life-cycle improvements to improve product performance and overall customer experience, this position will be responsible for external supplier engagement relating to design, process and quality consistency impacting customer experience.
The ability to partner and provide technical leadership with Supplier Quality/External Manufacturing and Manufacturing Engineering/Operations will be paramount for this position.

Key Responsibilities:
Guided by customer feedback, identify and clearly articulate the customer and business opportunities
Independently develop, design and implement product quality solutions to improve on-market product quality and services.
Manage complex multi-functional projects that require project management leadership skills and delivery of business prioritized projects.
Proactively monitor, attend focus groups, analyze, and improve all aspects of product performance.
Solution development may include prototyping of instruments and implants which may require test method development and validation.
Serve as a Customer Experience Champion and lead change management across functions and serve as a conduit to Commercial functions.

Bachelor's Degree in Mechanical Engineering or equivalent scientific/technical field required; advanced degree preferred

Experience and Skills:
A minimum 3 years of relevant work experience.
Part Manufacturing and Product Engineering experience
3D CAD and ability to create detailed part drawings using Geometric Dimensioning & Tolerancing.
Strong project management experience
Ability to lead, motivate, influence, and supervise cross-functional teams
Composition, execution, and analysis for development and characterization protocols
Experience in Design of Experimentation (DOE) and problem-solving methodologies
Technical understanding of manufacturing equipment, processes, and product design
Excellent communication, interpersonal and organizational skills
Understanding of GMP/ISO regulations or validation practices in a regulated environment
Experience working across functions to deliver complex projects
Advanced technical training in statistics or Process Excellence certification
Design Analysis Software (e.g., Finite Elemental Analysis)
initab Experience
Experience with automation technologies

Requires up to 10% travel, domestic and international

Keywords: Pioneer Data Systems, Irvine , Engineer 2, Engineering , Irvine, California

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