Manufacturing Engineer II

Innovize; Saint Paul (MN); On-site; USD 75,000 - 95,000; Full time

Job summary

A leading company in the medical manufacturing sector is seeking a Manufacturing Engineer II for production support. This mid-level role focuses on improving manufacturing processes, validating equipment, and applying Lean Six Sigma methodologies. Candidates should have a BSME degree and 4-10 years of relevant experience in a medical manufacturing environment, demonstrating both technical expertise and leadership in achieving safety and quality goals.

Qualifications

• 4-10 years experience in a medical manufacturing environment.
• Experience with IQ/OQ/PQ validation activities for medical products.
• Green or Black Belt in Lean Six Sigma preferred.

Responsibilities

• Improve manufacturing processes and troubleshoot problems using Lean Six Sigma/DMAIC.
• Assess and qualify material changes for production jobs.
• Ensure compliance with GDP, GMP, CFR 820, and ISO13485.

Skills

Lean Six Sigma

Root cause analysis

Communication

Statistical techniques

Project Management

Education

BSME from an accredited university

Tools

CAD (Solid Edge or Solid Works)

Job description

Job Description

Title: Manufacturing Engineer II (Production Support)

Reports to: Senior Manager, Operational Continuous Improvement

Summary: This position is responsible for mid-level manufacturing engineering and production support at Innovize. Duties include improving manufacturing processes for existing products, evaluating and acquiring new or replacement equipment/ tooling, writing and executing IQ/OQ/PQ validation protocols and assisting with reports. With occasional guidance from the Senior Engineering staff this individual will provide hands-on technical support for Lean Six Sigma Manufacturing initiatives like DMAIC problem solving, SMED, Preventive Maintenance, Value Stream Mapping, 5S, Visual Workplace, Process Mapping, DOE, Gage R&R, CpK, and SPC/Control Charting.

Duties/Responsibilities include but are not limited to:

• 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.

Accountabilities:

• 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.

Training/Education/Experience:

• 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)

Competencies/Talents/Personal Attributes:

• 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.

Evidence of Success: (Must be limited to two statements and must focus on critical HISTORICAL work performance of potential applicants. For an applicant to be considered for the job, they must show "evidence of success" in their previous jobs of delivering the results that are stated here. If an applicant would be hired despite not being able to show a history of this performance, then that item should not be stated here. These should be the absolute top two items that are critical for the selected for hire applicant must be able to show previous work historical success with.)

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