DePuy Synthes is a Johnson & Johnson company that is one of the leaders in the medical device industry. Our implants and instruments are used by orthopaedic surgeons to treat patients with conditions resulting from traumatic injuries, degenerative diseases, deformities, and sports related injuries. Our environment is entrepreneurial, learning-driven, and is as challenging as it is rewarding.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
The Sr. Manufacturing Engineer leads and supports the development of engineering processes and process improvements in order to product high quality product in the most effective manner.
POSITION DUTIES & RESPONSIBILITIES:
• Understand various types of product or process requirements by reviewing design documentation and feedback from Product Development groups.
• Support team project planning activities, especially by providing engineering project plans and timeline portions.
• Lead engineering related project meetings as necessary to convey project updates and status.
• Develop and/or implement processes that meet product design requirements.
• Evaluate, adjust and/or optimize processes for achieving acceptable capability levels
• Be able to maintain and reference lists of process related vendors, materials, supplies, equipment, and documents
• Determine, rate, and/or finalize process risks by drafting a thorough Process Failure Mode & Effects Analysis (PFMEA)
• Determine relationships between process parameters and critical outputs
• Measure process outputs against product specifications
• Identify necessary process controls
• Determine process operating parameters, ranges, and boundary conditions
• Participate in determining appropriate analytical equipment and performing Measurement Systems Evaluations / Analysis
• Lead or participate in performing Measurement Systems Evaluations / Analysis on analytical equipment, tools, or gages
• Generate, maintain, and present process flow maps
• Participate in the development of project Validation Master Plans (VMPs)
• Generate process related documentation
• Apply formalized root cause analysis formats to problem solving
• Implement lean / six sigma principles to processes as necessary
• Identify, provide detailed specifications, and obtain quotes on manufacturing scale equipment, materials, tools, fixtures, and supplies
• Lead or support the procurement of raw materials, tooling, fixtures and packaging components for validation execution
• Create manufacturing and quality assurance documentation needed to transfer processes to their final manufacturing location
• Work with the site manufacturing engineers to transfer the process into production.
• Conduct and/or aid site manufacturing in validating production equipment
• Obtain funding for capital equipment through appropriation request process
• Order, install, and validate equipment and processes when necessary
• Evaluate processes for manufacturing capacity, unit cost, and scrap potential
• Execute processes to provide material for various validations, shelf life tests, and shipping tests.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times
• Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer
· Bachelor’s degree required. Engineering, Chemical Engineering, or Bioengineering preferred.
· 4 years experience Manufacturing Engineering experience required
· Experience leading and participating in complex projects preferably in the medical device, biotechnology, and/or pharmaceutical industries required
· Ability to handle process development, root cause analysis, equipment procurement, process implementation, and/or validation (IQ, OQ, PQ) is required
· Understanding of six sigma, lean sigma, and process capability principles is required
· Exceptional verbal and written communication skills; Good presentational skills, High attention to detail is required
· Excellent organizational and multi-tasking competence is required
· Ability to work effectively independently or in a team setting is requiredPrimary Location
DePuySynthes Products Inc (6149)Job Function
Process EngineeringRequisition ID
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