Manufacturing Engineer II

• Use systematic approach (Lean Six Sigma/DMAIC and root cause analysis problem solving tools) when troubleshooting manufacturing problems (especially ICARS, SCARS, and CARS) to ensure that the appropriate system wide corrective actions are made to prevent recurrence.
• With occasional guidance from Senior Engineering, provide lead technical role in ensuring that when development jobs are transferred to production, all necessary equipment, tooling, and processes have been properly developed, validated, and documented to ensure consistent production of high quality product at or below the quoted cost.
• Assess, test and qualify material changes (Supplier Notification of Change) for existing production jobs.
• Actively seek out, prioritize, propose, and implement cost savings opportunities that will have the greatest impact on Innovize profits.
• Understand and comply with GDP, GMP, CFR 820 and ISO13485 requirements.
• Complete other duties as assigned.

• Accountable for meeting the Safety goals.
• Accountable for meeting the Quality goals.
• Accountable for meeting the On Time Delivery goal.
• Accountable for Cost Savings equivalent to at least 2 times base salary.

• College graduate with BSME from an accredited university and 4 – 10 years experience in a medical manufacturing environment.
• Experience applying Lean Six Sigma Manufacturing methodology for problem solving (Green or Black Belt preferred).
• Experience with regulatory requirements like ISO, GMP, CAPA and others.
• Experience with IQ/OQ/PQ validation activities for medical products.
• Experience with performance metrics.
• Strategic planning and implementation skills (Project Management).
• Proficient PC skills.
• Proficient in CAD (Solid Edge or Solid Works preferred)

• Excellent communication skills, written and verbal with ability to lead meetings and effectively present in front of a group.
• Strong math skills with ability to understand and apply statistical techniques such as means, standard deviations, control limits, process capability (CpK), histograms, Gage R&R, and SPC/control charting.
• Ability to read blueprints, to understand geometric dimensioning and tolerances, and to sign off drawings as originator or checker.
• Ability to work effectively on computers, to collect data, to create graphs, to create process flow diagrams and draw work center or facility layouts.
• Demonstrates initiative and independence: Proactively seeks new opportunities and exhibits self-confidence, is action oriented and makes things happen, despite apparent roadblocks.
• Demonstrates organization, planning, and follow-through: Plans, organizes, and schedules efficiently. Effectively manages multiple projects, establishes contingencies, delivers on promises, and completes the required documentation.
• Demonstrates a commitment to understanding medical manufacturing and ISO13485 regulations through active participation in company training as well as through self-education by reviewing ISO13485 regulations, reading related articles, and attending seminars.
• Able to challenge existing assumptions using a fact-based scientific approach coupled with ingenuity to guide teams toward effective solutions to problems.
• Can speak, understand and write English.

• Safety goals are met.
• Quality improvement goals are met (Reduced NCs/DMRs).
• On Time Delivery goals are met.
• Cost Savings goals are met.

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