ESSENTIAL JOB RESPONSIBILITIES:
- Evaluate manufacturing processes based on quality criteria, such as efficiency and speed
- Study production and machine requirements
- Develop and test effective automated and manual systems
- Design and install equipment
- Organize and manage manufacturing workflows and resources
- Integrate disparate systems (e.g. equipment handling, transport)
- Optimize facility layouts, production lines, machine operations and network performance
- Resolve issues and delays in production
- Find ways to reduce costs and maximize quality
- Train staff in new and existing processes
- Collaborate with other engineers, contractors and suppliers
- Ensure that manufacturing procedures follow safety and environmental regulations
- Upgrade systems and processes with new technology
- Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.
- Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
- Prepare detailed reports or design statements based on results of tests or reviews of procedures and protocols.
- Complete, compile, review and submit all protocol documentation and submit for cross-functional approval.
- Prepare, maintain, or review compliance documentation such as planned deviation requests, engineering change notices, schematics, or protocols.
- Assist in training equipment operators or other staff on standard operating procedures.
- Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
- Resolve testing problems by modifying testing methods or revising test objectives and standards.
- Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
- Continuously improve site processes and procedures by:
- Ensuring compliance with corporate guidelines and FDA requirements
- Networking with counterparts at other manufacturing sites to share best practices
- Evaluating impact of procedural and equipment changes on process validation
MINIMUM REQUIREMENTS:Education and Experience (in years):
Bachelor’s degree in with 2+ years of work-related experience.
Knowledge, Skills and Qualifications:
- Must have a strong background in Plastic Injection Molding (in the medical arena preferred)
- Previous experience as a manufacturing engineer or similar role
- Knowledge of manufacturing processes, fabrication methods and tool design
- Familiarity with manufacturing equipment and quality assurance techniques
- Commitment to health and safety standards and environmental regulations
- Well-versed in relevant software (e.g. CAD, MS Office)
- Project management skills
- Problem-solving ability
- Teamwork skills
- Ability to occasionally work late shifts
- Degree in Engineering; post-graduate degree is a plus
- Extensive experience with validation activities such as equipment qualification (IQ, OQ, and PQ)
- 5 years’ experience in a Medical Device Manufacturing Environment regulated by FDA
- Six Sigma, Lean, 5S, Kaizen process improvement project background
- Excellent organization, communication [speaking and listening] and computer skills
- Injection Molding Experience
- Quality Engineering Background
- Engineering Degree
- Project Management Professional [PMP] certification
- CAD software experience [SolidWorks, AutoCAD, Pro/E]
- Light duty office and cleanroom working environment
- Sitting at computer workstation
- Walking throughout factories to gather information and communicate with key team members
- Some part and equipment inspection
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available .