What are the responsibilities and job description for the Manufacturing Engineer III position at TekOne IT Services Pvt. Ltd.?
Job Title: Manufacturing Engineer III
Location: Mansfield, MA 2048
Key Responsibilities
Location: Mansfield, MA 2048
Key Responsibilities
- Collaborate with cross-functional teams, including Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, and Manufacturing, to optimize and support processes for surgical product manufacturing.
- Design, specify, and procure tooling, fixtures, and equipment for manufacturing.
- Lead the implementation and validation of new or modified manufacturing processes and equipment.
- Facilitate internal and external process transfers with suppliers.
- Assist in selecting and validating replacement materials such as polymers, metals, and adhesives.
- Develop, implement, and maintain Manufacturing Procedures, Work Instructions, BOMs, Routers, and DMRs.
- Act as a technical expert in process engineering, providing solutions to manufacturing issues and driving continuous improvement efforts to reduce rework, scrap, and labor variance.
- Support Material Review Board activities by investigating and resolving manufacturing and supplier quality issues.
- Introduce new manufacturing technologies and industry best practices.
- Represent Manufacturing Engineering in strategic Manufacturing and Sourcing projects.
- Bachelor’s degree in Mechanical, Manufacturing, Materials, or Biomedical Engineering (or equivalent) required.
- At least 6 years of engineering experience, with a background in the medical device industry.
- Proficiency in GMP, ISO 13485 Design Control, and manufacturing process qualifications (IQ, OQ, PQ) related to medical devices.
- Knowledge of manufacturing processes (e.g., metal and plastics processing, mechanical assembly) and machine, tool, and equipment design.
- Experience working in a cleanroom environment is preferred.
- Familiarity with Six Sigma and Statistical Process Analysis (certification preferred).
- Ability to mentor Black Belts/Green Belts and utilize Minitab software as needed.
- Proven experience in troubleshooting, analyzing, and improving manufacturing processes to enhance uptime, yield, and product quality.
- Background in Lean Manufacturing and Continuous Improvement preferred.
- Understanding of financial accounting for assessing product costs, project values, and capital purchases.
- Strong communication, team-building, and cross-functional coordination skills.
- Experience with Agile and Oracle data systems preferred.
- Ability to work onsite 40 hours per week in Mansfield, MA, with up to 10% domestic travel.
