Manufacturing Engineer II

The Manufacturing Engineer will provide onsite production support for Medical Device manufacturing. This role is responsible for supporting day-to-day manufacturing operations, product transfers, and process validation activities to ensure safe, efficient, and compliant production. The position operates as an individual contributor within the Specialist career stream and works cross-functionally with Engineering, Quality, and Manufacturing teams.

Key Responsibilities - Responsibilities may include, but are not limited to:

• Provide hands-on production support to troubleshoot manufacturing process and equipment issues.
• Inspect performance of machinery, equipment, and tools to verify efficiency and product quality.
• Investigate manufacturing deviations, identify root causes, and initiate corrective and preventive actions.
• Support continuous improvement initiatives to enhance process efficiency and product performance.

• Support product and process transfers into manufacturing for Cryo-Ablation Probes.
• Adapt machine, equipment, and tooling designs to factory and production conditions.
• Collaborate with engineering teams to ensure design concepts and specifications align with manufacturing capabilities.

• Design and maintain manufacturing processes, procedures, and production layouts.
• Develop and support validated manufacturing processes, including inspection and test requirements.
• Ensure manufacturing processes are applicable to and support Statistical Process Control (SPC).
• Incorporate quality and regulatory requirements into production plans.

• Ensure all manufacturing processes and procedures comply with applicable regulatory, quality, and safety standards.
• Support audits, inspections, and documentation requirements as needed.

• Communicate regularly with internal stakeholders to share status, needs, risks, and issues.
• Participate in cross-functional project teams to achieve project milestones.
• May provide guidance and mentoring to entry-level professionals or support personnel.

Required Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 1-5 years of relevant manufacturing or process engineering experience
  • (Minimum 2 years of experience required with a bachelor's degree; advanced degree may substitute for experience.)
• Practical knowledge of manufacturing processes, equipment, and process validation.
• Strong critical-thinking, problem-solving, and communication skills.
• Ability to work independently with general supervision on moderately complex assignments.

Preferred Qualifications

• Experience supporting medical device manufacturing.
• Familiarity with regulated manufacturing environments (ISO, FDA, GMP).
• Experience with process validation, SPC, and product transfers into manufacturing.