Job Title: New Product Introduction Engineer

Job Description

This role is specifically focused on New Product Introduction (Pre-commercial) processes, ensuring successful integration of new products into manufacturing systems.

Responsibilities

• Lead, facilitate, and support PFMEA risk management activities.
• Collaborate with suppliers to validate components used in finished assemblies.
• Conduct equipment and process validations.
• Manage supplier risk and validate internal master plans and report writing.
• Develop and execute internal validation protocols and report writing, including IQ, OQ, PQ, and PPQ.
• Perform measurement systems analysis and test method validations, such as Gage R&R.
• Resolve non-conformance and corrective/preventive actions for new products.

Essential Skills

• Expertise in New Product Introduction.
• Proficiency in risk management and validation processes.
• Experience in supplier collaboration and production part approval.

Additional Skills & Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related field.
• 0-2+ years of experience in a manufacturing environment.

Work Environment

The work environment involves a dynamic split between office settings and the manufacturing floor, offering exposure to high-profile projects.