Engineer - R&D Engineer III - Veterans Sourcing Group
Valencia, CA 91355
About the Job
Job Description: Hybrid
About the role:
• Provides engineering support for integration activities for an acquisition.
• This position is a contract role, expected to complete by the end of July 2025.
• Provides oversight of the design, quality, manufacturing, and project related activities.
• Coordinates with internal functions and external suppliers to identify and execute projects.
• Applies project management and problem solving skills to manage multiple activities concurrently. Develops products, materials, processes, or equipment for projects of moderate complexity. Under limited supervision/guidance, compiles, analyzes, and reports operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials.
• 5 - 15% domestic travel possible
Your responsibilities include:
• Ensuring all Design Controls aspects of an acquisition are remediated through:
o Developing new requirements, sourcing new requirements, creating and validating new test methods, creating new risk documentation, and performing all applicable testing
• Supporting manufacturing moves from one vendor to another.
• Supporting project work for EUMDR approval.
• Maintains product safety, quality, and compliance of all products.
• Trained in all aspects of change management (DCA, SCIA, SCAR, and PLCP).
• Supports any applicable R&D projects planning and activities.
• Understands and complies with all the regulations governing the quality system.
• Supports additional activities required by the business.
What we're looking for:
• 2+ years working with design controls.
• 2+ year project leader/manager experience.
• 2+ years working within FDA Quality System Regulations and ISO 13485.
• Experience with assessing quality and compliance impact on products for design and process changes.
• Experience with design verification and validations activities.
• Experience with Test Method development.
• Experience in troubleshooting and root cause analysis.
• Self-motivated individual that can work independently.
• Working knowledge of MiniTab and SolidWorks.
• Good writing (assessments, protocols, reports, and email) and verbal communication skills.
Preferred Qualifications
• Has led 4+ projects to drive product design changes or process changes preferred.
• 3+ years Electro/Mechanical experience.
• Has participated in 4+ new product development projects, related product transfer and scale-up activities preferred.
• Knowledge of manufacturing processes including; silicone molding, laser welding, resistance welding, small part assembly, cleanroom operations, vision inspection systems, soldering, electronic component assembly, electrical testing and packaging.
• SAP and Windchill experience is a plus.
• Human Factors / Usability experience is a plus.
Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Qualifications
5 - 8 Years with BS, 3 - 6 Years with MS, 0 - 3 Years with PhD
OT: Eligible for 1.40 OT Mark-Up:
About the role:
• Provides engineering support for integration activities for an acquisition.
• This position is a contract role, expected to complete by the end of July 2025.
• Provides oversight of the design, quality, manufacturing, and project related activities.
• Coordinates with internal functions and external suppliers to identify and execute projects.
• Applies project management and problem solving skills to manage multiple activities concurrently. Develops products, materials, processes, or equipment for projects of moderate complexity. Under limited supervision/guidance, compiles, analyzes, and reports operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials.
• 5 - 15% domestic travel possible
Your responsibilities include:
• Ensuring all Design Controls aspects of an acquisition are remediated through:
o Developing new requirements, sourcing new requirements, creating and validating new test methods, creating new risk documentation, and performing all applicable testing
• Supporting manufacturing moves from one vendor to another.
• Supporting project work for EUMDR approval.
• Maintains product safety, quality, and compliance of all products.
• Trained in all aspects of change management (DCA, SCIA, SCAR, and PLCP).
• Supports any applicable R&D projects planning and activities.
• Understands and complies with all the regulations governing the quality system.
• Supports additional activities required by the business.
What we're looking for:
• 2+ years working with design controls.
• 2+ year project leader/manager experience.
• 2+ years working within FDA Quality System Regulations and ISO 13485.
• Experience with assessing quality and compliance impact on products for design and process changes.
• Experience with design verification and validations activities.
• Experience with Test Method development.
• Experience in troubleshooting and root cause analysis.
• Self-motivated individual that can work independently.
• Working knowledge of MiniTab and SolidWorks.
• Good writing (assessments, protocols, reports, and email) and verbal communication skills.
Preferred Qualifications
• Has led 4+ projects to drive product design changes or process changes preferred.
• 3+ years Electro/Mechanical experience.
• Has participated in 4+ new product development projects, related product transfer and scale-up activities preferred.
• Knowledge of manufacturing processes including; silicone molding, laser welding, resistance welding, small part assembly, cleanroom operations, vision inspection systems, soldering, electronic component assembly, electrical testing and packaging.
• SAP and Windchill experience is a plus.
• Human Factors / Usability experience is a plus.
Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Qualifications
5 - 8 Years with BS, 3 - 6 Years with MS, 0 - 3 Years with PhD
OT: Eligible for 1.40 OT Mark-Up:
Source : Veterans Sourcing Group