Description

You will own process development, continuous improvement, and new product introduction for medical device manufacturing.

This role is on-site.

Responsibilities

• Lead New Product Introduction (NPI) activities within a medical device environment.
• Execute process validation activities, including IQ, OQ, and PQ.
• Design and implement manufacturing test fixtures.
• Conduct Failure Mode and Effects Analysis (PFMEA) to mitigate risks.
• Apply DMAIC methodology and statistical tools to drive process improvements.

Required Skills

• 6+ years of professional working experience in medical device manufacturing.
• Hands-on experience with process development and process characterization.
• Proficiency in process validation protocols (IQ, OQ, PQ).
• Experience designing and building test fixtures.
• Familiarity with PFMEA methodologies.
• Knowledge of statistical analysis using Minitab.
• Experience applying Gage R&R, Cp, Cpk, and SPC to improve processes.

Preferred Skills

• Any Graduate degree.

Key Skills

Education

Any Gradute