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

Pharmavise Corporation; California (MO); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Pharmavise Corporation seeks a Sr. R&D Engineer to provide engineering support for design control activities, coordinating cross-functional efforts across design, quality, manufacturing and project execution.

The role involves working with internal teams and external suppliers, managing multiple projects and contributing to development and improvement of products and processes. Based in Valencia, CA, the position is hybrid with a 6-month contract.

Qualifications

• 5+ years in design controls and regulatory knowledge.
• Experience with FDA QSR and ISO 13485 compliance.
• Ability to develop and validate test methods.
• Strong problem solving and data analysis skills.
• Proficiency with SolidWorks and statistical tools.
• Excellent technical writing and verbal communication.

Responsibilities

• Oversee design, quality, manufacturing, and project activities.
• Coordinate with internal functions and external suppliers to execute projects.
• Apply project management and problem solving to manage multiple activities.
• Develop products, materials, processes, or equipment for moderate complexity.
• Ensure all design controls aspects are met.
• Support manufacturing moves between vendors.

Skills

Design controls

FDA QSR compliance

ISO 13485

Test method development

Root cause analysis

MiniTab

SolidWorks

Technical writing

Tools

SAP

Windchill

Job description

Valencia, United States | Posted on 03/19/2026

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

Job Description

Overview:

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.

Responsibilities:

• 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 design ed 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.
• Design ing and developing new tools and fixturing using Solidworks for use in test method development and validation.
  

Required Qualifications:

• 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.
  

Preferred Qualifications:

• 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.
  

Other Details:

Schedule: 08:00:AM - 04:30:PM

Work Setup: Hybrid in Valencia, CA

Contract Duration: 6 Months in Valencia, CA (4/13/2026 - 10/13/2026)

Pharmavise Corporation is an Equal Opportunity Employer and does not discriminate on the basis of race or ethnicity, religion, sex, national origin, age, veteran disability or genetic information or any other reason prohibited by law in employment.