Job Title: Manufacturing Engineer

Job Description

We are seeking a skilled Manufacturing Engineer to join our dynamic and innovative team. This role focuses on improving production processes and ensuring compliance with quality and regulatory standards. You will lead efficiency improvement projects and collaborate with cross-functional teams to align project goals and timelines.

Responsibilities

• Conduct time studies and analyze production data to identify areas for improvement.
• Lead efficiency improvement projects and track their impact on production processes.
• Work closely with cross-functional teams, including marketing, IT, and customer service, to ensure alignment on project goals and timelines.
• Monitor and report on key performance indicators (KPIs) such as First Pass Yield (FPY), cycle time reduction, and cost savings.
• Facilitate continuous improvement events and Lean Six Sigma projects.
• Ensure compliance with regulatory standards and quality requirements in all manufacturing processes.
• Develop and implement robust manufacturing processes for existing products.
• Ensure a seamless transition from product development to full-rate production, ensuring process stabilization.
• Develop and qualify new tooling and equipment to enhance production capabilities.
• Design and draft workspace layouts, including materials and equipment, using computer-aided design (CAD) software.
• Update risk documents (FMEA’s) and Quality Control Plans for New Product Introduction.
• Conduct verification and validation (IQ/OQ/PQ) of processes, machines, and equipment to meet company procedures and regulatory requirements.
• Create and maintain routers and standards for manufacturing processes.
• Troubleshoot product and process-related issues, performing root cause analysis and implementing corrective and preventative action plans.
• Collaborate with vendors to identify and implement operational equipment and automation solutions.
• Develop and manage project plans for major operational improvement activities.

Essential Skills

• 3-5 years of experience working as a Manufacturing Engineer in the medical device industry.
• Experience in process development and process improvement.
• Supporting design transfer and process improvement for Class III medical devices, including catheters.
• Proven experience in manufacturing process validation.

Additional Skills & Qualifications

• Bachelor’s Degree in Engineering or a related field.
• Excellent communication and technical writing skills for preparing reports and collaborating with cross-functional teams.

Work Environment

The role is situated within a medical device manufacturing environment, renowned for its breakthrough cardiovascular and endovascular solutions. The team consists of 8 members and operates Monday to Friday, with flexible hours from 8:00 AM to 5:00 PM, accommodating earlier or later start times such as 6:00 AM to 3:00 PM or 9:00 AM to 6:00 PM. Limited overtime is expected. The work environment is collaborative and fast-paced, fostering innovation and growth.