Process Development Engineer

11 hours ago

Brooklyn Park, Minnesota, United States Cirtec Medical Full time
Job Summary

The Process Development Engineer II position is primarily responsible for designing, developing, and qualifying manufacturing processes for the manufacture of medical devices.

This role will be involved in the design, development, documentation, and validation of new customer products, and modification of existing products, including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Key Responsibilities
  • Attend and arrange project meetings to discuss current and future design and development initiatives.
  • Act as a primary contact with customers on programs of low to moderate complexity and 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.
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.
Requirements
  • A bachelor's degree (STEM engineer discipline preferred) and 2 years of experience required, or a combination of education and relevant work experience.
  • Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred).
  • Willingness to travel, if required.
  • Maintain high ethical standards.
  • Demonstrate good organizational skills.
  • Read, write, and speak fluent English.
  • Strong computer skills, including MS Office.
  • Experience with Minitab and statistical analysis.
  • Experience with documented change control processes.
  • Fully interpret technical drawings, blueprints, specifications, and illustrations.
  • Strong analytical skills, obtain, evaluate, and apply secondary research information.
  • Ability to learn and apply new technology.
  • Technical report preparation and formal presentation skills.
Working Environment

Work is performed in an office environment. The noise level in the work environment is usually moderate.

EEO Statement

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law.

Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

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