Engineering Manager - Medical Device Manufacturing

ARCH Medical in Elmhurst, IL is looking for talent! Passionate about manufacturing? Do you take pride in contributing to our vision to create the best possible solutions for our customers? Empathetic to share our mission of saving people’s lives with the tools we produce? We want to be your employer of choice! Join our Team and take pride in producing high-quality surgical products! We are a team of about 70 formal and informal leaders who are passionate about what they do, get the work done and still have fun! 

Manufacturing Engineer works to improve manufacturing and production processes using lean manufacturing and other improvement concepts. This includes collecting production data, analyzing outputs, determining corrective actions, project management, evaluating existing processes and configuring manufacturing systems to improve quality, reduce cost, improve sustainability, and develop best practices within the production process, while embracing the Core Principles:

• Engaged Employees: All employees have an obligation to understand, who we are, why we are here and where we are going.
• Customer Driven: Everything we do is driven by our passion to support our customers.
• Results Oriented: Good intentions and taking action are not enough – we need to get results
• Respectful Communications: It is okay to disagree – it is not okay to be disagreeable
• Fairness: We will be fair in our dealings with each other, our customers and suppliers, and our communities.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Lead in optimization of set-up cycle times and improvement of productivity standards by teaming with operators and set-up personnel
• Investigate, experiment, and implement processes to maximize productivity
• Maintain reliable and safe manufacturing systems while improving production rates, efficiencies, yields, costs, and changeovers.
• Evaluate current processes, determine their effectiveness, identify opportunities, and recommend strategies for improvement
• Collect, record, and transcribe data.
• Perform root cause analysis and corrective actions on external and internal complaints to improve processes.
• Work with equipment designers and manufacturing officers to develop a cost-effective and working production process.
• Research and purchase new manufacturing technology.
• Selection and development of tools and fixtures for improvements.
• Perform process Failure Mode and Effect Analysis.
• Provide tactical coaching on Lean Methodology and Continuous Improvement Techniques (Six Sigma).
• Lead process improvement projects to meet business objectives and deliver quantifiable results using lean and six sigma methodologies.
• Actively lead Kaizen events and other lean activities as part of project deliverables or supporting other initiatives.
• Assist in leading lean implementation and layout optimization for new product development projects in the plant.
• Lead Operational Excellence deployment plan in plant.
• Mentor and train operations staff on lean principles.
• Install organizational supports for Continuous Improvement (reviews, communications, rewards, software).
• Create and maintain an environment of continuous improvement by actively managing projects to improve overall quality.
• Continuously challenges the status quo understood as a day-to-day activity in the section / business unit.
• Proactive problem solving on the basis of statistical analysis of corrective actions.
• Plan data and actual measurable report, monitoring and improving selected measurables.
• Performance information and reports on processes.
• Participate and present in operations and quarterly business reviews as required.
• Ensure projects are completed on time.
• Ensure financial budgets are followed.
• Ensure Engineering Masters are entered and current.
• Overall responsibility for Customer Order review and manufacturability.

Supervisory Responsibilities:  Directly supervises 5-10 employees in the Engineering. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Competencies

To perform the job successfully, an individual should demonstrate the following competencies:

• Adaptability
  • Accepts criticism and feedback
  • Adapts to changes in the work environment
  • Changes approach or method to best fit the situation
  • Manages competing demands
• Cooperation
  • Displays positive outlook and pleasant manner
  • Establishes and maintains effective relations
  • Exhibits tact and consideration
  • Offers assistance and support to co-workers
  • Works actively to resolve conflicts
  • Works cooperatively in group situations
• Dependability
  • Commits to doing the best job possible
  • Follows instructions, responds to management direction
  • Keeps commitments
  • Meets attendance and punctuality guidelines
  • Responds to requests for service and assistance
  • Takes responsibility for own actions
• Problem Solving
  • Develops alternative solutions
  • Gathers and analyzes information skillfully
  • Identifies problems in a timely manner
  • Resolves problems in initial stages
  • Works well in group problem solving situations
• Teamwork
  • Balances team and individual responsibilities
  • Contributes to building a positive team spirit
  • Exhibits objectivity and openness to others' views
  • Gives and welcomes feedback
  • Puts success of team above own interests

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience

Bachelor’s degree in industrial engineering, degree in related field; or four to ten years related experience and/or training; or equivalent combination of education and experience. Knowledge of ISO 13485 Quality Management System & FDA 21CFR 820 Regulations and Knowledge of Geometric Dimensioning and Tolerance per ASME Y14.5M. Strong understanding/experience with milling, turning, Swiss turning. Analytical skills, project management, and Six Sigma Black Belt certification preferred.

Language Skills

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format.

Mathematical Skills

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis.

Reasoning Ability

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills

To perform this job successfully, an individual should have knowledge of ERP/Epicor preferred, MS office suite; Solidworks; Inventory software; Internet software; Order processing systems and Manufacturing software.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The employee must regularly lift and /or move up to ten pounds, frequently lift and/or move up to twenty-five pounds. Specific vision abilities required by this job include Close vision, Distance vision, Peripheral vision, Depth perception and Ability to adjust focus. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee is frequently required to stand; walk; sit; climb or balance and stoop, kneel, crouch, or crawl.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently exposed to work near moving mechanical parts. The noise level in the work environment is usually loud.