Senior Process Development Engineer

ZipRecruiter; Minneapolis (MN); On-site; USD 75,000 - 95,000; Full time

Job summary

A leading company in the engineering sector is seeking a Process Engineer to support major product development projects. The ideal candidate will oversee process design, characterize and validate new products, and ensure robust manufacturing processes. A bachelor's degree in engineering and extensive experience in process engineering are required for this dynamic role.

Qualifications

• 5+ years experience in engineering, 2+ years in process engineering.
• Hands-on experience with QSR CFR 820, ISO 13485, ISO 14971.

Responsibilities

• Oversee process design, development, characterization, and validation for products.
• Develop and manage strategy to bring processes from feasibility to launch.
• Identify process performance requirements and develop monitoring strategies.

Skills

Process design

Project planning

Problem solving

Manufacturability

Technical analysis

Education

Bachelors Degree in Engineering

Job description

Job DescriptionJob DescriptionSummary:

Develops and executes plans for major process related segments of complex product development projects. Compiles and analyzes process performance data to establish process design and specifications for newly designed or modified products. Plans and validates equipment and processes of newly designed products to internal and external requirements. Executes process development related activities on project. Reviews progress of projects; recommends appropriate revisions. Takes a leadership role in application and advancement of technologies developed by Switchback.

Essential Duties and Responsibilities (but are not limited to):

• Oversee process design, development, characterization, and validation for products in development.
• Work closely with R&D team, customers and leadership to define process specifications and performance requirements.
• Perform engineering and technical work involved in planning, organizing and coordinating detailed information required to develop new products from concept to final product realization.
• Develop and manage strategy to bring processes from feasibility to launch.
• Contribute to early development phases and be the voice of design for manufacturability.
• Identify suitable processes and equipment early in development and ensure robust manufacturable product design.
• Assume responsibility for overall manufacturing process of new and existing products.
• Devise new approaches to complex problems through revisions of standard technical principles.
• Help prepare project plans, specifications, resource plans, and schedules for new product development.
• Work closely with other engineers, technicians, contract manufacturers, assemblers, or other support personnel to oversee manufacturing products for development prototypes, design verification, process development and validation activities.
• Identify critical processes, and develop master process validation plans including IQ, PC, OQ, PQ and external service validations requirements for development projects.
• Work closely with other engineers and assemblers to characterize and validate equipment and processes.
• Identify process inputs and outputs and develop strategy for how to monitor and control.
• Identify process performance requirements (yield, capacity, capability, efficiency) that should be met before transfer to production and may be used as KPI’s.

Education/Experience:

• 5+ years experience in engineering. 2+ years of which are in process engineering.
• Bachelors Degree in engineering or equivalent.
• Must have hands-on experience and knowledge of QSR CFR 820, ISO 13485, ISO 14971 and other relevant standards.

This job description is intended to describe the general nature and level of work being performed by employees assigned to this position. It is not intended to be an entire list of all activities, tasks and skills required of employees in this position.