Katalyst Healthcares and Life Sciences
Job Location : Foxboro,MA, USA
Posted on : 2025-01-15T07:39:07Z
Job Description :
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 integra 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 integra 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 labour variance reduction / elimination in the plant processes.
- Supports Material Review Board process by investigating and resolving manufacturing and supplier quality concerns.
- Identifies and provides innovative new manufacturing technologies from industry best practices that can be applied to integra products and mfg processes.
- Represents the Manufacturing Engineering group on strategic projects in Manufacturing and Sourcing.
Requirements:
- Bachelor's degree in mechanical, Manufacturing, Materials or Biomedical Engineering or equivalent is required.
- 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.
- Knowledge of how to troubleshoot and analyse the effectiveness of manufacturing processes is required. Experience in implementing actions to improve equipment uptime, yield, efficiencies, and quality of production is required.
- Experience in Lean Mfg. 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.
- Position is in Mansfield, MA and requires onsite presence 40 hrs week.
- bility to travel up to 10% domestically is required.