A Manufacturing Process Engineer is responsible for developing and implementing manufacturing processes. They troubleshoot and solve operational, automation, and process-related problems to ensure robust manufacturing processes. In this blog post we describe the primary responsibilities and the most in-demand hard and soft skills for Manufacturing Process Engineers.

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Main Responsibilities of Manufacturing Process Engineer

The following list describes the typical responsibilities of a Manufacturing Process Engineer:

Achieve

Achieve or exceed performance objectives for schedule, cost, and quality.

Analyze

• Analyze business requirements, user needs, and system designs.

• Analyze complex problems and identify their impact.

• Analyze current equipment for process suitability and provides detailed plans for improvement.

• Analyze proposed changes for manufacturing impact and feasibility.

• Analyze repeated issues with equipment.

Apply

• Apply root cause fixes to prevent reoccurrence.

• Apply working knowledge of related disciplines.

Assess

Assess processes, take measurements and interpret data.

Assist in

• Assist in the management of R& D technical documentation.

• Assist purchasing and quality Assurance in qualifying new vendors, as needed.

Coach

• Coach, manage and develop technical staff.

• Coach, mentor, and provide guidance to other engineers and technicians.

Communicate

Communicate progress and conclusions to senior management and stakeholders.

Complete

Complete closed job reviews to translate lessons learned.

Conduct

Conduct process FMEAs and process validations.

Consult

Consult with operations team regarding operation data.

Contribute to

Contribute to P&IDs, PFDs and process descriptions.

Coordinate

• Coordinate activities with maintenance to resolve mechanical issues.

• Coordinate activities with PCS to resolve automation issues and changes.

• Coordinate and assist in pilot and production scale-up batches.

• Coordinate PLM system evaluation activities.

• Coordinate, select and schedule project engineers for Operations projects.

• Coordinate the design, procurement, build, and debug of tooling, machinery, and test equipment.

Create

• Create and maintain KPIs for manufacturing to monitor progress and changes in output or quality.

• Create and maintain KPI's to prioritize development direction and collaborate with executive team.

• Create or modify documentation requiring engineering technical knowledge.

Cultivate

Cultivate internal and external network of resources to complete tasks.

Design

Design and implement jigs, fixtures, and manufacturing aids.

Determine

Determine area / equipment interlocks.

Develop

• Develop and implement process improvement efforts and otherwise troubleshoot existing processes.

• Develop and lead programs to improve product and process / quality understanding.

• Develop and maintain process documentation.

• Develop and maintain product workflows in Camstar MES.

• Develop, document, and implement manufacturing processes for Matternet aircraft and accessories.

• Develop, document, qualify, and implement fixtures, and assembly / test equipment.

• Develop fixture design concepts to support new and existing processes.

Direct

• Direct the works of technical, clerical support and less experienced engineering staff.

• Direct the activities of these third-party resources to ensure equipment operates as intended.

Document

Document management system (PDOCS) with document authoring experience is preferred.

Drive

• Drive continuous improvement of engineering technical capabilities.

• Drive functional performance to ensure cross-functional standards and expectations are met.

• Drive understanding of key customer needs and monitors process capabilities.

Ensure

• Ensure a safe work environment consistent with OSHA requirements and St. Jude Medical policies.

• Ensure engineering solutions meet requirements for safety, cost, time, and quality.

• Ensure equipment requirements can meet processing needs.

• Ensure processes and procedures are in compliance with regulations.

• Ensure that ESD practices are followed.

Establish

• Establish and control project spending to budget by specifying and estimating project costs.

• Establish and cultivates an extensive network of support to facilitate completion of assignments.

• Establish equipment synchronization requirements.

• Establish priorities of individual or project assignments.

• Establish priorities of work assignments.

• Establish processes based on product specifications.

• Establish product specifications.

• Establish robust, repeatable and reproducible process parameters.

• Establish semi-complex design and process requirements.

Evaluate

• Evaluate and select various engineered materials.

• Evaluate design alternatives based on functionality, testability, manufacturability, and assembly.

• Evaluate machine logic, electromechanical systems and process controls to troubleshoot equipment.

• Evaluate process and design alternatives based on "Design for Manufacturability” principles.

Exercise

• Exercise authority and judgment within defined limits to determine appropriate action.

• Exercise judgment within defined procedures and practices to determine appropriate action.

Follow

Follow established company / department rules and regulations and maintain quality standard.

Generate

Generate ECOs to correct and improve assembly documentation.

Help

Help build and maintain capacity modeling for specific processes and equipment.

Hire

Hire and retain a diverse, highly qualified staff and provides ongoing performance feedback.

Identify

Identify, develop, qualify, and implement cost-saving opportunities.

Implement

• Implement and evaluate proposed designs and processes for manufacturability.

• Implement and manage resource planning and project management tools.

• Implement process improvement strategies to improve quality, reliability and / or reduce cost.

• Implement safety, productivity and yield improvements.

• Implement statistical process analysis on new and existing products.

Incorporate

Incorporate business policies and procedures into task completion.

Increase

Increase production rate through process optimization, organization, and continual improvement.

Influence

Influence exerted at peer level and occasionally at first levels of management.

Initiate

• Initiate and complete technical activities leading to new or improved products or processes.

• Initiate and work to resolve Quality Incidents and CAPA.

• Initiate or maintain schedule for projects and project milestones.

Interface with

Interface with production of all activities associated with new process implementation and transfer.

Lead

• Lead and / or participate on cross-functional teams to support organizational goals.

• Lead and participates in design, planning and introduction of Packaging production lines.

• Lead cost improvement / reduction programs.

• Lead Lean Six Sigma (LSS) projects.

• Lead or serve as member on cross functional project teams in a fast-paced, dynamic environment.

Leverage

Leverage industry best PLM practices for developing PLM software solutions for Abbott.

Maintain

• Maintain and update routing / operation sheets.

• Maintain a safe and professional work environment.

• Maintain inspection readiness of area.

• Maintain knowledge of new developments in electrical design technologies.

• Maintain knowledge of new developments in manufacturing and design technologies.

• Maintain office area and equipment in clean, safe, and orderly condition.

• Maintain related records, files, in up-to-date condition.

• Maintain relationships with contractors and equipment suppliers and service staffs.

Manage

• Manage area Standard Operating Procedures along with Manufacturing Supervisor.

• Manage capital projects to select, design, procure, install and qualify new manufacturing equipment.

• Manage cost and time constraints.

• Manage engineering project teams and coordinates activities.

• Manage multiple often concurrent projects.

Meet

Meet with vendors and other consulting advisors on the various company projects.

Mentor

• Mentor employees by sharing technical expertise and providing feedback and guidance.

• Mentor junior engineers and maintenance technicians.

Model

Model processes and units operations.

Monitor

• Monitor and evaluate project and department progress and results.

• Monitor product factory cost and initiates continuous improvement projects.

Optimize

Optimize facility layout, material and tool handling, work cells, and assembly line.

Oversee

Oversee new process equipment production.

Participate

• Participate and / or co-lead cross-functional teams in support of organizational goals.

• Participate in cross-functional teams.

• Participate in determining goals and objectives for projects.

• Participate in process operational improvements.

• Participate in the design, development, and launch of new products and processes.

• Participate to activities pertaining to cycle time and process improvements.

Perform

• Perform all other duties as per the company's needs and requirements.

• Perform analyses to develop design specifications and performance requirements.

• Perform data analyses to determine trends and conclusions.

• Perform detailed Design of Experiments (DOE) and analyze results using statistical methodology.

• Perform other related duties and responsibilities, on occasion, as assigned.

• Perform other related duties as required or directed.

• Perform risk assessments and ensure risk management forms are thoroughly completed.

• Perform root cause analysis and drive equipment reliability and process stability.

Plan

• Plan and organize non-routine tasks w / approval.

• Plan, organize, and prioritize own daily work routine to meet established schedule.

Prepare

• Prepare capital project requests and manage their implementation.

• Prepare cost estimates for process proposals / revisions for new and existing products.

• Prepare departmental budgets and control expenditures to stay within spending limits.

• Prepare justification, purchase and implement capital equipment for production.

• Prepare reports on material, product, or equipment performance for internal and external customers.

• Prepare reports, publish and make presentations on capital projects and related department metrics.

• Prepare reports, publishes, and makes presentations to communicate findings.

Present

Present data to equipment teams.

Provide

• Provide continuous development of manufacturing techniques that will improve in-house capabilities.

• Provide daily manufacturing support.

• Provide engineering support to assigned cells.

• Provide equipment maintenance and repair support as required.

• Provide feedback to Engineering teams to improve product designs for manufacturability.

• Provide guidance to less experienced staff.

• Provide input into the development of manufacturing processes and controls.

• Provide manufacturing support to new product introductions and in-sourcing products.

• Provide process documentation and operating instructions to include error proofing.

• Provide project management.

• Provide support in developing design specifications and performance requirements.

• Provide technical leadership to business units.

Recommend

Recommend appropriate action that would typically achieve departmental / project objectives.

Report

Report project implementation, cost and status to appropriate person.

Represent

Represent department / division on projects.

Research

Research, evaluate, justify, and recommend capital equipment for operations.

Review

• Review and approve protocol and written reports.

• Review and contribute to applicable documentation (i.e. MBRs, SOPs, etc).

• Review P&IDs and provide support as needed.

• Review pilot defects with Technical and Quality Assurance to establish range boards for production.

• Review processing methods.

Run

Run design of experiments studies to characterize process to improve yield and efficiency.

Select

Select techniques to solve problems and make sound design recommendations.

Set

Set complex design and process requirements.

Share

Share process and idea concepts during design and prototype phases.

Suggest

Suggest and support new methods or materials for continual improvement of quality and efficiency.

Support

• Support chemical / wet manufacturing processes, including etching, passivation, final cleaning.

• Support continuing production, process development and new product introductions.

• Support continuous improvement (CI) initiatives.

• Support of process development and equipment acquisition.

• Support of regulatory filings and inspections.

• Support project management activities to control scope, cost, schedule, and quality.

• Support site and focus factory resources with process improvements.

• Support technology transfer of drug product processes, both internally and to external CMO(s).

Track

Track and review Key Performance Indices.

Translate

Translate process descriptions instructions to meet production equipment / system capabilities.

Troubleshoot

• Troubleshoot and solve operational, automation, and process-related problems.

• Troubleshoot heat exchanger issues.

• Troubleshoot issues with drug product processing technologies and equipment.

• Troubleshoot process related issues.

Understand

• Understand and comply with applicable EHS policies, procedures, rules and regulations.

• Understand IP issues relative to processes being developed.

• Understand principles of "Cost of Goods Sold”.

• Understand principles of Cost of Goods Sold.

• Understand the business cycle and foresight of emerging technologies trends.

• Understand work environment issues (i.e. OSHA regulations, etc.).

Update

Update changes required during initial pilot run.

Use

Use in-depth knowledge of business unit functions and cross group dependencies / relationships.

Utilize

• Utilize automated equipment and process characterization.

• Utilize engineering skills and knowledge of engineering concepts, procedures and methods.

• Utilize production trial system for trial initiation and writing final reports.

• Utilize project management skills to organize and execute projects.

Work with

• Work closely with other Process Engineers on key projects and initiatives.

• Work in close liaison with all staff / operating personnel.

• Work to identify root cause of manufacturing failures using structured problem solving.

• Work well on cross-functional teams in a continuous improvement (LEAN) environment.

• Work with complex coating process of component parts.

• Work with engineers and equipment suppliers to define project scope, schedule and budgets.

• Work with manager concerning priorities of specific projects.

• Work with PCS to develop detailed automation design(s) and specifications.

• Work with Product Development to ensure design for manufacture.

• Work with Tech Services, Engineering, Automation, QA, etc to ensure robust manufacturing processes.

Most In-demand Hard Skills

The following list describes the most required technical skills of a Manufacturing Process Engineer:

1. Manufacturing

2. Continuous Sitting For Prolonged Periods

3. FDA Regulated Industry

4. Mechanics

5. Chemistry

6. Chemical Engineering

7. Process Engineering

8. Project Management

Most In-demand Soft Skills

The following list describes the most required soft skills of a Manufacturing Process Engineer:

1. Written and oral communication skills

2. Organizational capacity

3. Identifying technical problems and solving them with minimal guidance

4. Communicate at multiple levels in the organization

5. Attention to detail

6. Leadership

7. Multi-task