Manufacturing Engineer

Manufacturing Engineer
• Westminster, CO, United States

• Participate in the development and improvement of manufacturing processes for Smart Valve Manufacturing and catheter-based systems in accordance with FDA and international regulations.
• Evaluate, develop, and sustain processes to meet product performance and manufacturing yield requirements.
• Constantly identify opportunities to reduce cycle time and waste. Develop and implement plans to capitalize on these opportunities.
• Evaluate and modify process flow as necessary to improve efficiency.
• Develop tools, fixtures, and processes to meet product and process capability requirements.
• Create and maintain process validation master plan. Develop, qualify, and validate new manufacturing processes as needed.
• Manage activities with outside vendors that provide components, assemblies, manufacturing processes, testing, and other services.
• Build and validate test equipment, conduct testing of product, and analyze data as needed.
• Follow approved procedures for activities conducted and update or generate new procedures as needed.
• May supervise operators, technicians, or other engineers.
• Ensure that product development and manufacturing activities are performed in accordance with U.S. Quality System Regulations and ISO 13485.
• Assure individual and group safety when conducting all activities.
• Maintain effective communications with supervisor and peers in project activities.
• As necessary, suggest strategic direction for specific projects.
• Support day-to-day manufacturing activities.

Education &

Certifications:

• Minimum of four-year engineering degree or equivalent experience.

Work Experience:

• 0-2 years experience in a medical device manufacturing environment is required.

Knowledge, Skills & Abilities:

• Cardiovascular catheter experience preferred; will consider candidates with self-expanding stent experience.
• Knowledge with chemistry and good laboratory practices.
• Familiarity with Six Sigma principles preferred.

Physical Requirements:

• Able to work in an industrial environment.