Gentuity, LLC

Manufacturing Engineering Manager

Gentuity, LLC Sudbury, MA
Gentuity, LLC

Manufacturing Engineering Manager

Gentuity, LLC Sudbury, MA
3 months ago 30 applicants

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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.

  • Seniority level

    Mid-Senior level

  • Employment type

    Full-time

  • Job function

    Engineering and Information Technology

  • Industries

    Medical Equipment Manufacturing

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