Senior Process Engineer

What you'll do

• Provide technical and sustaining engineering support for manufacturing areas to improve production yields and efficiency.
• Implement equipment and process modifications to ensure products meet quality standards and manufacturing requirements.
• Lead the innovation, development, and optimization of new manufacturing concepts and procedures for production transfer.
• Conduct statistical analysis and develop measurement systems suitable for statistical process control.
• Ensure all manufacturing processes and procedures comply with regulatory standards such as FDA QSR and ISO 13485.
• Perform root cause analysis and lead investigations into nonconformances to implement corrective actions.
• Execute technology transfers, scale-up activities, and cost reduction initiatives for existing and new products.
• Develop technical documentation including protocols, reports, and submissions to support manufacturing operations.

What we're looking for

• Must have a Bachelor's degree with 4 years experience, a Master's with 2 years experience, or a PhD.
• An engineering degree is required.
• Must hold Lean Manufacturing and Six Sigma Green Belt or Black Belt certification.
• Proficiency in advanced statistical analysis including DOE, SPC, MSA, and process capability studies.
• Experience in equipment qualification and validation leadership (IQ/OQ/PQ).
• Knowledge of risk management tools such as FMEA and Fault Tree Analysis.
• Regulatory knowledge of FDA QSR, ISO 13485, and GMP standards.
• Work authorization at the time of hire and for the duration of employment.