Sr. R&D Engineer— Medical Device (Hybrid – Valencia, CA) Contract

Pharmavise Corporation•Santa Clarita, CA

3d•Hybrid

About The Position

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at www.pharmavise.com and follow us on LinkedIn: https://www.linkedin.com/company/pharmavisecorp Our F500 Medical Device client has an exciting opportunity for a Sr. R&D Engineer. Job Summary: This Sr. R&D Engineer role provides engineering support for design control activities while overseeing cross-functional efforts across design, quality, manufacturing, and project execution. The position involves coordinating with internal teams and external suppliers, managing multiple projects using strong problem-solving and project management skills, and contributing to the development and improvement of products, processes, and materials of moderate complexity.

Requirements

5+ years working with design controls.
5+ 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.

Nice To Haves

Has led 4+ projects to drive product design changes or process changes preferred.
3+ years Mechanical design experience.
Has participated in 4+ new product development projects, related product transfer and scale-up activities preferred.
SAP and Windchill experience is a plus.
Human Factors / Usability experience is a plus.

Responsibilities

Provides engineering support for design control activities.
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.
Ensuring all Design Controls aspects
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.
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.
Designing and developing new tools and fixturing using Solidworks for use in test method development and validation.