What are the responsibilities and job description for the Manufacturing Engineer position at Fusion Life Sciences Technologies LLC?
Job Title: Manufacturing Engineer III
Location: Mansfield, MA (Onsite)
Duration: 6 Months
Neurosurgery devices/disposables
Sealing equipment and sterile barriers experience is a MUST NEED
Med device experience is HIGHLY preferred and these candidates will be shortlisted first
Automation experience i.e.- PLC, logic, optical controls, electromechanical
Validation experience - writing or protocols/executing/technical drafting required
Essential Duties and Responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Primary responsibilities are to:
• Works within cross-functional project teams including Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, and Manufacturing to maintain and improve manufacturing processes used to manufacture surgical products for the medical device industry.
• Designs, specifies, develops, and purchases manufacturing tooling, fixtures and equipment.
• Manages the implementation and validation of new or modified manufacturing processes and equipment to support the manufacture of client products.
• Support and guide transfers internally within plant and externally with suppliers.
• Supports the selection and validation of replacement materials, such as polymers, metals, and adhesives used in the manufacturing of client products.
• Writes and implements Manufacturing Procedures and Work Instructions.
• Creates, updates and maintains BOMs, Routers, and DMRs.
• Works as a recognized manufacturing and process technical expert who can provide process engineering knowledge and oversight to resolving manufacturing-related problems with existing products and processes.
• Champions improvement processes for rework, scrap, and labor variance reduction / elimination in the plant processes.
Desired Minimum Qualifications:
• Bachelor's degree in Mechanical, Manufacturing, Materials or Biomedical Engineering or equivalent is required.
• A minimum of 6 years of engineering industry experience is required.
• Experience in the medical device industry is required.
• Knowledge of GMPs, ISO 13485 Design Control, and Manufacturing Process IQ, OQ, PO qualifications as related to medical devices is required.
• Working knowledge in manufacturing processes such as metal processing (machining, polishing, welding), plastics processing, and mechanical assembly is required.
• Working knowledge of machine and tool design, equipment design, and the startup of new equipment is preferred.
• Experience working in a cleanroom environment is preferred.
• Six Sigma Statistical Process Analysis knowledge is required with certification preferred.
• Mentor and assist Blackbelts/Greenbelts on projects as needed. Assist with tools and Mintab software.
• Experience in Lean manufacturing and Continuous Improvement Methods is preferred.
• Knowledge of financial accounting and analysis methods to assess product standard costs, project values, product cost improvements and capital purchases is required.
• Strong communication, team building, and cross-functional coordination skills are required.
• Experience with Agile and Oracle data systems is preferred.
• Ability to travel up to 10% domestically is required
