Senior Manufacturing Engineer

About the Role

The Sr. Manufacturing Engineer provides support and solutions by leveraging general knowledge of manufacturing processes to increase plant efficiencies and meet, or exceed, goals related to safety, quality, and production. The role involves employing software tools to aggregate test data, troubleshoot equipment, and develop layout drawings. The ideal candidate will demonstrate deep technical knowledge, excellent communication and organizational skills, and strong personal ownership of initiatives.

Responsibilities

• Plan, organize, and implement systems and procedures for aiding in the manufacturing of MVE products while enhancing flow, and implement Lean concepts (e.g., 5S, Visual Work, Kanban) throughout the plant.
• Conduct and/or supervise studies to determine cause, effect, and corrective measures required to remedy deviations impairing desirable standards of quality.
• Analyze and plan workflow, equipment placement, and space requirements to improve manufacturing efficiency.
• Partner with Design Engineering groups to ensure proper transition of new product introductions and changes to existing products into manufacturing.
• Develop and perform qualification and validation activities for newly introduced equipment, processes, and products.
• Partner with production, engineering, and maintenance departments and apply formal problem-solving tools (e.g., 5 Why’s, 8D, Ishikawa diagram) to resolve assembly errors and eliminate variances.
• Work closely with team members to identify and eliminate waste activities.
• Identify, recommend, and justify opportunities for capital equipment improvements.
• Project management of capital equipment projects, ensuring on-time delivery, managing budgetary constraints, and ROI.
• Perform hands-on mechanical and electrical troubleshooting of production equipment, including some PLC troubleshooting.
• Observe and promote safety procedures and policies.
• Other duties and responsibilities as assigned by management.

Requirements

• BS degree in Engineering, preferably Manufacturing, Mechanical, or Industrial.
• 3–5 years of relevant Medical Device Manufacturing experience; or a minimum of 10 years of experience in a related field, reflecting an increase in scope and complexity of duties and responsibilities.
• Six Sigma Black Belt certification required, with a proven track record of leading and delivering measurable process improvement projects.
• Working knowledge of computers, including MS Word, Excel, and SolidWorks.
• General familiarity with medical device or similar quality systems requirements.
• Understanding of MIG/TIG welding practices, sheet metal fabrication, cryogenics, and vacuum systems (a plus).
• Understanding of factory metrics, Lean (Operational Excellence), and Six Sigma (a plus).
• Knowledge and understanding of company safety procedures and policies, quality standards, capital equipment procurement, FMEA, APQP, ISO 13485, MDD/MDR, and FDA regulations.

Skills & Attributes

• Team player mentality with a passion for, and alignment with, MVE’s mission.
• Strong core values, including quality, ethics, and integrity.
• Collaborative mindset with a focus on accountability.
• Strong work ethic and ability to deliver results in a dynamic environment.
• Exceptional communication skills with the ability to inspire and influence others.
• Efficient prioritization and drive toward corporate goals.
• Exceptional organizational and planning skills, strong analytical abilities, and process orientation.
• Business process orientation to developing solutions.

Physical Work Environment

• Ability to work in both an office and production environment.
• Occasional travel to customers, vendors, or other MVE locations.
• Ability to sit, stand, and/or walk for 8 hrs/day.
• Occasional lifting of up to 30 lbs., with occasional heavier lifting.
• Occasional pushing, pulling, and handling of materials.
• Production floor environment may involve exposure to materials with rough edges, temperature extremes, moving mechanical parts, occasional flying debris, and chemical cleaning solvents and their odors.
• Ability to move around the production floor and lab areas to address production issues relating to products and equipment.
• Working with cryogenic products may involve exposure to pressurized flammable gas, pressurized oxidizing gas, pressurized inert gas, and very low temperatures (-320º F).