Manufacturing Engineering Manager Job at Gentuity, LLC in 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.

• Experience with ISO 13485 and FDA Quality System Regulations
• Experience with Minitab or other statistical evaluation software
• Lean Six Sigma training or certification and knowledge of statistical data analysis techniques (DOE, GR&R, Cpk, SPC)
• Risk management experience (DFMEA, PFMEA)
• CAD experience (preferably SolidWorks)
• PD experience is preferred
• Demonstrated project management skills with ability to prioritize multiple concurrent projects in a fast-paced environment and identify/resolve issues as they arise with minimal supervision.
• Cross functional team player with a strong work ethic, strong engineering and problem-solving skills, creative thinking, good decision-making skills, high attention to detail, effective interpersonal skills and excellent verbal/written communication skills.
• Experience with biomedical fiber optic components and processing is a plus.

EDUCATIONAL REQUIREMENTS:

• Bachelor’s degree in mechanical or biomedical engineering (or related Engineering degree) plus minimum of 7 years of experience working in an FDA/ISO regulated medical device/medical equipment industry or equivalent education and years of experience.