Manufacturing Engineering Manager (Sudbury)Gentuity, LLC • Sudbury, MA, US
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Manufacturing Engineering Manager (Sudbury)
Gentuity, LLC • Sudbury, MA, US
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job_description.job_card.job_descriptionExperience 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. Bachelors 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.
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 :
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Manufacturing Engineering Manager • Sudbury, MA, US