Manufacturing and Process Development Engineer II

SUMMARY: In this position, the Manufacturing and Process Development Engineer II will play a critical role in measuring Quality, On Time Delivery, and Cost (QDC) indicators, analyzing performance data, improving methods and technology, and controlling solutions for long-term sustainability. They will provide daily support and take ownership of continuous improvement activities for medical device coating processes in an ISO 13485, Medical Device manufacturing environment.

RESPONSIBILITIES:

As a Manufacturing and Process Development Engineer II, you should be a hands-on technical problem solver, with strong notetaking and documentation skills, capable of working within a multi-disciplinary team, and maintain a high-level of organization. Outstanding Manufacturing and Process Development Engineers provide data driven solutions to complex technical problems utilizing a combination of problem-solving tools, including lean manufacturing principles, design and analysis software, and advanced manufacturing and metrology equipment.

Initiate and lead in the design, development, and implementation of manufacturing processes and technologies to increase revenue or improve product quality, operational efficiency, and cost-effectiveness of existing products.

• Partner with Project Management, New Production Introduction (NPI) Engineering, Quality Assurance/Quality Engineering, and Supply Chain teams to ensure seamless integration of new products and processes into manufacturing.
• nterpret customer requirements from manufacturing prints or product specifications and designs manufacturing process to meet those requirements.
• Ensure adherence to regulatory requirements and industry standards including verification of complete documentation with good documentation practices (GDP).
• Document Process Development activities on Process Development Reports (PDR) or Engineering Test (ET) protocols.
• Support Test Method Validation (TMV) activities and understand the use of Gage R & R test to make informed decisions about inspection methods.
• Create and maintain detailed documentation, including process routings, part inspection work instructions, and business process work instructions.
• Design, fabricate, or source fixtures and tooling using CAD.
• Process Validation including Master Validation Plan (MVP), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Design of Experiment (DOE).
• Train manufacturing personnel in new processes and technologies. Provide ongoing support to ensure successful implementation and adoption of process improvements.
• Initiate and lead a culture of Continuous Improvement by applying lean manufacturing principles to streamline operations, reduce waste, and enhance productivity.
• Participate in the Non-Conforming Material process including disposition and root cause analysis and develop effective corrective and preventive actions (CAPA) countermeasures.
• Demonstrates regular use of Engineering Problem Solving Tools (DMAIC, A3, Fishbone Diagrams, 5 Why, etc) to solve complex technical problems.
• Implement and analyze Statistical Process Control (SPC) charts, including mean and range control charts, upper and lower control limits, and demonstrates ability to identify how to react and implement solutions to process trends
• Compare and contrast new equipment and technologies, perform return on investment calculations, establish implementation costs, and present to leadership for approval through CAPEX process.
• Develop and implement preventative, predictive, and prescriptive maintenance (PM, PdM, and RxM) measures including identifying and sourcing high likelihood and high impact spare components and consumables to reduce Mean Time to Repair (MTTR).
• Project management experience, leading the implementation of capital equipment, new product introduction, or process development and qualification.
• Create and maintain Value Stream Maps for existing and new processes to understand where value is created, and waste exists.
• Eliminate Waste (Muda) including Overproduction, Waiting, Transport, Motion, Overprocessing, Inventory, and Defects to improve productivity.
• Demonstrate use of Single Minute Exchange of Dies (SMED) principles, including identifying internal and external tasks to maximize machine utilization and reduce changeover time.

Supervisory Responsibility

• Supervision and workload management of an Engineering Technician may be required.
  • If supervision and work assignment of an Engineering Technician is required
    • This role will be responsible for ensuring an Engineering Technician is supporting production as required, reporting on assigned projects, and work is aligned with organization goals.

ESSENTIAL QUALIFICATIONS:

• Bachelor s Degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or related field from an accredited college or university.
  • Manufacturing Engineering minor or concentration a plus.
• 3-6 years of hands-on professional experience in manufacturing and process development within the medical device industry (ISO 13485 or FDA regulated).
  • 2-4 years of experience with an advanced degree in Engineering or related field.
• Familiarity with FDA regulations and ISO standards related to medical devices preferred
• Microsoft Office (Word, Excel, PowerPoint, Outlook, Publisher)
• Technical Skills
  • Design and/or CAD experience (SolidWorks, AutoCAD, or similar)
    • Create parts, designed for additive manufacturing, machining.
    • Create assemblies with a variety of mating types.
    • Create drawings in Metrics and Standard units
    • Experience with tolerance stack analysis, BOMs, exploded views, section views, and GD&T tolerancing
    • SolidWorks CSWA Certificate preferred
  • Statistical Analysis experience (Minitab, JMP, Excel, or similar)
  • Experience in root cause analysis and problem-solving methodologies (e.g., 5 Whys, Fishbone Diagram).
  • Lean Six Sigma Green Belt
  • Lean Six Sigma Black Belt preferred
  • 1+ years of experience programming Fanuc, ABB, or equivalent industrial or collaborative robots.
  • Understanding the stress-strain curve and effects of heat exposure and phase changes of medical grade materials.
• Other Skills
  • Self-reports project and work status without being prompted.
  • Effectively and professionally communicates information and responds to questions in person-to-person and small group situations with customers, clients, and other employees of the organization.
  • Maintains confidentiality and uses discretion with sensitive business information.
  • Reads and understands documents such as policy manuals, safety rules, operating and maintenance instructions, and procedure manuals; Writes routine reports and correspondence.
  • Demonstrates high level of organization, planning, and execution.
  • Brings a positive attitude and can-do mindset every day.

KEY SUCCESS FACTORS:

• Make Quality Personal. Take pride in the quality of everything you do.
• Think Team First. Be there for each other and be willing to step into another role or help a co-worker when that s what s required for success.
• Be Relentless About Improvement. Find ways to get things done better, faster, and more efficiently.
• Deliver Results. Follow up on everything and take responsibility to ensure that tasks get completed. Hold yourself accountable for achieving results.
• Reduce or Eliminate Waste. Look for opportunities to eliminate wasted time, money, materials, and effort.
• Fix Problems at the Source. Address issues by finding the root cause.

PERSONAL PROTECTION EQUIPMENT:

• Following items are available as needed:
  • Safety glasses are required in designated areas
  • Uniform/Jacket issued by the company must be worn in designated areas.
  • Which also may include Tyvek suits, Hard Hat, Gloves, Protective Eyewear, Safety Shoes, assigned Uniform, NFPA-70E equipment, Respirator.

PHYSICAL DEMANDS: The employee is required to walk, reach with hands and arms, and occasionally sit, stoop and crouch. Requires mental and visual attention to detail as well as hand coordination. Occasionally lifting or moving average weight material. The flow of work and character of duties involve normal mental and visual attention along with manual coordination or part-time normal and part-time concentrated attention and coordination.

LANGUAGE SKILLS: Employee must be able to read and interpret documents written in English. Employees must be able to have good communication with fellow employees, supervisors, and management.