Apply on Employer Site

Cirtec Medical · 23 hours ago

R&D Engineer II

Brooklyn Park, MN

Full-time

Onsite

Entry, Mid Level

$80K/yr - $100K/yr

2+ years exp

Cirtec Medical specializes in the design and development of complex medical technologies. The R&D Engineer II position is responsible for designing and developing catheters, qualifying manufacturing processes, and supporting the development and validation of new and existing medical devices.

ManufacturingMedical Device

No H1B

Responsibilities

Attends and arranges project meetings to discuss current and future design and development initiatives

Serve as a primary contact with customers on programs of low to moderate complexity and serve as secondary contact with customers on programs of moderate to high complexity

Track and communicate the status of assigned action items that would affect timelines and budgets

Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner

Assist in the preparation and maintenance of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Provide input to program management for tracking and communicating project status, plans, issues, timelines, action items, and budgets

Responsible for the following project inputs: Feasibility builds, documentation, root cause analysis, and testing Equipment selection and qualification Process development and documentation Device Verification samples and testing Operator training Process Failure Mode Effects Analysis Clinical builds Process Validation

Involvement in the full design, development, and validation requirements of programs, including: Product design and specification creation, including mechanical and electrical components, assemblies, and packaging, Materials sourcing and device prototyping, Design verification and validation activities, including data for regulatory submission, Manufacturing transfer and support of existing product lines as applicable

Qualification

R&D EngineeringProcess DevelopmentMedical Device ExperienceStatistical AnalysisTechnical Report PreparationComputer SkillsAnalytical SkillsLearn TechnologyFluent EnglishOrganizational Skills