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MillenniumSoft Inc · 1 month ago

R&D Engineer (Product Development) - Exp in Medical Device Industry

San Diego, CA

Full-time

Hybrid

Mid, Senior Level

5+ years exp

MillenniumSoft Inc is seeking an R&D Engineer with experience in the Medical Device Industry. The role involves developing and managing products through medical device design control processes, collaborating with cross-functional teams, and executing design verification testing.

Staffing & Recruiting

No H1B

Responsibilities

Drive R&D deliverables throughout the medical device design control process for intravenous infusion sets and connection devices

Collaborate within a cross-functional team to plan, develop, modify, implement, and support IPD products through the application of rigorous engineering practices

Engineer robust products through strong understanding and application of engineering fundamentals and DFSS principles

Develop technical plans and guide the team to develop design inputs, conduct analytical and empirical feasibility studies, refine product configurations and designs, verify and validate subsystems and systems, concurrently transfer designs alongside Manufacturing and Operations, and provide design documentation to support global Regulatory filing strategies

Execute design verification testing to confirm design outputs meet design input requirements

Qualification

Medical Device Design ControlSolidWorksMechanical EngineeringCritical ThinkingProject ManagementCross-Functional CollaborationVerbal CommunicationWritten Communication

Required

BS - Mechanical Engineering, Materials Engineering or Biomedical Engineering

Work experience 5 years or 3 years plus an advanced degree

Critical thinking - able to work with moderate guidance in own area of knowledge

SolidWorks or equivalent CAD tool

Ability to manage multiple projects of varying scopes in parallel

Ability to work leading or as part of a cross-functional team with members from marketing, sales, clinical, regulatory, medical affairs, quality, manufacturing, etc

Experience with medical device design control processes and creating and maintaining design control documentation