Senior Manufacturing Engineer - Component Manufacturing

Medtronic Inc. Danvers , MA 01923

Posted 1 week ago

Careers that Change Lives

MAIN PURPOSE OF JOB

Develops manufacturing methods, systems, equipment and processes on existing products to produce a high quality product at optimal cost.

MAIN JOB DUTIES/RESPONSIBILITIES

  • Meet or exceed Manufacturing goals and objectives.

  • Develop and implement process and product improvements. Typically projects of complex scope and wide magnitude.

  • Equipment and Fixturing: Determine specific requirements of manufacturing operation in order to specify equipment, fixturing, and process parameters. May collaborate on design with suppliers to fulfill equipment and fixturing requirements.

  • Qualification and Validation: Develop plans to evaluate process repeatability and stability through equipment qualification and process validation.

  • Continuous Improvement and Cost Analysis: Improve manufacturing methods, optimize product performance and reduce manufacturing costs in a systematic fashion. Deploy Lean 6 Sigma methodology to identify and evaluate opportunities for improvement inherent in manufacturing processes and make specific recommendations for adoption.

  • In partnership with Finance, perform detailed cost analyses of manufacturing changes.

  • Production Support and Trouble Shooting: Provide engineering support to manufacturing operation. Address related issues arising on the production floor. May form and lead inter-disciplinary teams to resolve high profile production issues and document recommended corrective actions using the quality systems procedures. (NCMR & CAPA) Ability to lead Failure Investigations.

  • Develop and Optimize Work Design, Manufacturing Layout and Product Flow: Using Lean Manufacturing principles, recommend and implement process layouts for efficient manufacturing. Recommend appropriate staffing levels to support manufacturing requirement.

  • Define and generate all required documentation in support of manufacturing protocols, reports, manufacturing instructions and procedures. These include: Engineering protocols, reports, manufacturing instructions and procedures. Ensure compliance with GMPs and internal protocol. Use appropriate statistical support and Design of Experiments (DOE) when developing recommendations.

  • Compare internal yield/external complaint failure model with the process FMEA and accurately assess quality impact.

  • Lead teams in operations related programs including product iterations, cost reduction programs, process changes across product lines and manufacturing layout synergies.

  • Lead the work, manage and develop the talent of direct reports.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

  • Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.

  • Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.

  • Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.

  • Adapts machine or equipment design to factory and production conditions.

  • May incorporate inspection and test requirements into the production plan.

  • Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.

  • Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.

  • Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.

  • Ensures processes and procedures are in compliance with regulations.

Must Have: Minimum Requirements

Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Is A Bachelor's Degree Required? Yes

Nice to Have

  • BS in Engineering discipline (Manufacturing, Mechanical, Industrial, Operations Research, etc.)

  • 5-10 of years increasingly complex engineering responsibilities in a manufacturing environment

  • Engineering experience with disposable medical devices

  • Equipment and process Design and Development

  • Experience with developing equipment and related processes especially molding equipment and polymer bonding

  • 2-5 years experience in an ISO13485/GMP environment

SKILLS/COMPETENCIES:

  • Design of Experiments, process validation equipment development (IQ/OQ/PQ)

  • Some travel required.

  • Small tooling design and development

  • Knowledge of polymer materials and related processes

  • Electro-Mechanical troubleshooting skills

  • Medtronic Engineer Technical Certification

  • Verbal, written and presentation skills

  • Technical writing skills

  • Microsoft Project

  • Strong statistical skills using Minitab

  • Six Sigma, Constraint Management and Lean Manufacturing experience preferred

  • Project management experience

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Day in the Life section of this job description 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.


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VIEW JOBS 12/4/2018 12:00:00 AM 2019-03-04T00:00 Careers that Change Lives MAIN PURPOSE OF JOB Develops manufacturing methods, systems, equipment and processes on existing products to produce a high quality product at optimal cost. MAIN JOB DUTIES/RESPONSIBILITIES * Provide expert technical support for Manufacturing to meet or exceed goals and objectives. * Develop and implement process and product improvements. Typically projects of complex scope and wide magnitude. * Equipment and Fixturing: Determine specific requirements of manufacturing operation in order to specify equipment, fixturing, and process parameters. May collaborate on design with suppliers to fulfill equipment and fixturing requirements. * Qualification and Validation: Develop plans to evaluate process repeatability and stability through equipment qualification and process validation. * Continuous Improvement and Cost Analysis: Improve manufacturing methods, optimize product performance and reduce manufacturing costs in a systematic fashion. Deploy Lean 6 Sigma methodology to identify and evaluate opportunities for improvement inherent in manufacturing processes and make specific recommendations for adoption. * Support the transfer of new products and processes from process development to operations. Serve as the technical manufacturing expert to provide feedback during the development cycle and represent operations with the introduction into manufacturing, initial ramp, and stabilization of processes. * In partnership with Finance, perform detailed cost analyses of manufacturing changes. * Production Support and Trouble Shooting: Provide engineering support to manufacturing operation as well as mentorship and coaching to more junior engineers. Address related issues arising on the production floor. Lead inter-disciplinary teams to resolve high profile production issues and document recommended corrective actions using the quality systems procedures. (NCMR & CAPA) Ability to lead Failure Investigations. * Define and generate all required documentation in support of manufacturing protocols, reports, manufacturing instructions and procedures. These include: Engineering protocols, reports, manufacturing instructions and procedures. Ensure compliance with GMPs and internal protocol. Use appropriate statistical support and Design of Experiments (DOE) when developing recommendations. * Compare internal yield/external complaint failure model with the process FMEA and accurately assess quality impact. * Lead the work, manage and develop the talent of direct reports. A Day in the Life Responsibilities may include the following and other duties may be assigned. * Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. * Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. * Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. * Adapts machine or equipment design to factory and production conditions. * May incorporate inspection and test requirements into the production plan. * Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. * Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. * Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. * Ensures processes and procedures are in compliance with regulations. 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Yes Nice to Have * BS in Engineering discipline (Manufacturing, Mechanical, Industrial, etc.) * MS in Engineering Discipline preferred * 10 -15 of years increasingly complex engineering responsibilities in a manufacturing environment * Engineering experience with disposable medical devices * Equipment and process Design and Development * Experience with developing equipment and related processes especially molding equipment and polymer bonding * 7 - 10 years experience in an ISO13485/GMP environment SKILLS/COMPETENCIES * Design of Experiments, process validation equipment development (IQ/OQ/PQ) * Project management experience * Some travel required. * Small tooling design and development * Knowledge of polymer materials and related processes * Electro-Mechanical troubleshooting skills * Medtronic Engineer Technical Certification * Verbal, written and presentation skills * Technical writing skills * Microsoft Project * Strong statistical skills using Minitab * Six Sigma, Constraint Management and Lean Manufacturing experience preferred Team dynamic skills (communication, accountability, decision-making, feedback, meeting management, managing conflict). 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The physical demands described within the Day in the Life section of this job description 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. Medtronic Inc. Danvers MA

Senior Manufacturing Engineer - Component Manufacturing

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