Location: Mahwah, NJ
- Support the development and introduction of new orthopedic products.
- Work extensively with Product Development, Quality and Operations to take a product from design concept through production ramp up.
- Participate in multifunctional teams, led by a Project Manager and be responsible for defined project deliverables.
- Manage new equipment installation activities with the facilities team to deliver the work on schedule and budget.
- Create and release QMS documentation and Preventive Maintenance schedule for multiple manufacturing equipment including CNC milling, Bead Blast, Laser engraving, Coordinate Measuring Machine (CMM), robotic tending equipment, etc.
- Create documentation in the validation system for Master Validation Plan, Process Qualification, Factory Acceptance Test, Site Acceptance Tests, Equipment Qualification, and Measuring System Analysis (GR&R)
- Execute equipment validations, process qualification, and GR&R studies.
- Manage Engineering Change Notices for new products from creation to final approval
- Operate within the quality system to produce documentation such as process validations, equipment qualifications, dynamic control plans, inspection plans and standard operating procedures
- Manage suppliers and resolve supplier issues, particularly for Supplier Innovation role.
- Manage small to medium project timelines.
- Operate within the ‘New Product Development Process’ [NPDP], to build robust processes through involvement in ‘Design for Manufacturability’ and ‘Lean Manufacturing’ initiatives
- Utilize Six Sigma process tools such as ‘Define, Measure, Analyze, Improve, Control’ (DMAIC), ‘Failure Modes & Effects Analysis’ (FMEA), ‘Design of Experiments’ (DOE), Gage Repeatability & Reproducibility’ (Gage R&R), ‘Statistical Process Control’ (SPC), capability analysis as required
- Perform dimensional and visual inspection to blueprint and guide sheets using CMM, standard gages, customized gauges and comparators
- Bachelor’s degree in a science degree, preferably Engineering.
- 5+ years of engineering experience in a manufacturing environment (Medical device preferred)
- Demonstrated fundamental understanding and or strategy of creating equipment validation documentation.
- Demonstrated fundamental understanding of manufacturing processes.
- Demonstrated experience managing suppliers and resolving supplier issues, particularly for Supplier Innovation role.
- Demonstrated experience managing small to medium project timelines.
- Ability to work independently with low supervision.
- Ability to meet project milestones and deadlines on time.
- Identify Risk, issues - Resolve using Mitigation tools
- Demonstrated familiarity with theory and practical application of ‘Geometric Dimensioning & Tolerancing’ (GD&T) - Must demonstrate basic knowledge
- Demonstrated proficiency in Microsoft Outlook, Microsoft Project, Microsoft Visio and Microsoft Office applications
- Demonstrated interpersonal, communication and presentation skills. Must be comfortable presenting at department level meetings
- Must be challenged by a team-based environment which places a high degree of emphasis on accountability for customer satisfaction, cost reduction and quality/GMP compliance
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
Failure Mode Effects Analysis
Coordinate Measuring Machine (Cmm)
Define Measure Analyze Improve And Control (Dmaic)
Statistical Process Controls