Manufacturing Engineering Manager (Sudbury)

SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES :

• Lead and mentor a team of manufacturing engineers and equipment technicians to achieve Operations goals.
• Design and develop manufacturing processes, tooling, and fixtures that enhance safety, quality, and productivity. Own line layout and space utilization in all cleanrooms.
• Provide engineering support for equipment qualifications and process validation (IQ / OQ / PQ), including protocol development, execution, data analysis, and reporting.
• Develop work instructions, standards, and process documents, train operators and technicians accordingly.
• Lead root cause analysis and corrective actions for production issues, product defects, customer complaints, and other technical challenges.
• Manage design transfer activities ensuring completion per project plans and meeting production capability targets.
• Drive continuous improvement initiatives to enhance quality, productivity, workflow, reliability, efficiency, and cost savings using tools such as Gage R&R, Cp, Cpk, and SPC.
• Monitor and report manufacturing and quality metrics; support investigations and corrective actions for non-conforming products, CAPAs, and customer returns.
• Collaborate with R&D and Quality to address process performance issues and support prototype, pilot production, and product changes.
• Manage and update manufacturing documentation and ensure process validation for manufacturing transfer and scale-up.
• Support resolution of supply chain and component obsolescence issues, including supplier / customer coordination.
• Assist with regulatory approvals and responses related to existing products.
• Communicate project progress, risks, and recommendations to management proactively.
• Perform additional tasks as needed to support team and organizational success.

EXPERIENCE / SKILL REQUIREMENTS :

Minimum of 7 years of manufacturing engineering experience in a medical device production industry with a minimum of 2 years of supervisory experience.

EDUCATIONAL REQUIREMENTS :