Senior Medical Device R&D Engineer - Design & Compliance

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

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.