The manufacturing engineer has two primary responsibilities: designing manufacturing processes for optimum efficiency; lead root cause investigations. Both require strong leadership skills as well as working knowledge of manufacturing statistics. This position is responsible for ongoing life-cycle process performance. Key metrics include process efficiency, scrap, and first pass yield.
Duties and Responsibilities
- Working knowledge of manufacturing validation process for healthcare products.
- Working knowledge of statistics and an ability to determine the appropriate variables to analyze for statistical analysis.
- Ability to analyze a new manufacturing process and determine the critical variables as well as output analysis for process monitoring.
- Construct engineering studies and designs of experiment in order to characterize manufacturing processes.
- Design and manage value stream maps for key manufacturing processes with an understanding of the appropriate performance metrics for success.
- Ability to lead continuous improvement activities such as Kaizen events and six sigma projects.
- Generate engineering reports for process validations and test analysis.
- Lead project teams for root cause investigation, validation strategies, and process design.
- Develop project analysis plan, including computer-generated table specifications, statistical analysis plan, and research report format.
- Verify statistical programs, statistical results, and data sets used in statistical section of technical documents.
- Co-operate in further development of internal guidelines and SOPs.
- Problem Solving – Develops alternative solutions. Gathers and analyzes information skillfully. Identifies and resolves problems in a timely manner. Uses reason even when dealing with emotional topics. Works well in group problem solving situations.
- Adaptability – Ability to adapt to frequent changes, delays, or unexpected events and still yield an effective outcome. Adapts to changes in the work environment. Changes approach or method to best fit the situation. Manages competing demands
- Judgment – Recognizes important information quickly and grasps its implications. Makes timely, sound decisions, even under conditions of risk, uncertainty, and incomplete information. Includes appropriate people in decision-making process. Accepts accountability for decisions by ensuring follow through and effective implementation
- Analytical – Collects and researches data to formulate into a comprehensive result or report. Designs work flows and procedures. Synthesizes complex or diverse information. Uses intuition and experience to complement data.
- Team Work – Balances team and individual responsibilities. Contributes to building a positive team spirit. Exhibits objectivity and openness to views and opinions of coworkers. Puts success of team above own interests. Recognizes accomplishments of other team members. Supports everyone’s efforts to succeed
- Technical Skills – Assesses own strengths and weaknesses. Pursues training and development opportunities. Shares expertise with others. Strives to continuously build knowledge and skills.
Education, Experience, and Skills
- Bachelors degree in engineering or statistics.
- At least 5 years of experience in a manufacturing environment. Medical device or pharmaceuticalexperience required.
- Must be familiar with Microsoft Office Suite and Windows applications
- Good communication/interpersonal skills.
- Detail oriented with good organization and prioritizing skills
- Good trouble shooting and problem solving skills
- Ability to convey conclusions and recommendations concisely in properly formatted, well-writtenreports
- Excellent verbal and written communication and interpersonal skills