Manufacturing/Process Development Engineer I-II

Nextern•Maple Grove, MN

About The Position

Join the growing team NP and help bring innovative medical device technologies to life. This role is perfect for someone who enjoys learning new processes, solving technical challenges, and working hands-on with advanced manufacturing technologies. If you are curious, collaborative, and excited to continuously expand your knowledge, you’ll fit right in with our team. Come be part of an environment where innovation, teamwork, and continuous learning drive everything we do. Key responsibilities include: Coordinates product enhancements with customers and internal project teams Help generate all required documentation in support of the development and manufacturing products and processes, including timelines, responsibilities, engineering protocols, IQ, OQ, PQ reports, bill of materials, assembling instructions, manufacturing instructions and procedures. Work with quality and supply chain to ensure compliance with QSR and internal protocols. Review design and determine required Bill of Materials (BOM) Work with supply chain to obtain BOM pricing (from internal and external vendors) Support customer calls and presentations to compile product sustaining activities Provides support in the resolution of product complaints and/or safety issues. Help to conduct component and device testing methods and protocols. Identify risks to manufacturing sustainability- provide input to pFMEA and other risk assessment documentation Works with internal manufacturing as well as outsourced partners to develop metrics such as labor time, yields, statistical analysis, qualification and validation of process, tooling and equipment.. Transfer as required engineering project from engineering into manufacturing.

Requirements

Bachelor's Degree in Engineering and one to three years of related experience and/or training, or equivalent combination of education and experience.
Commitment to excellence and high standards
Excellent written and oral communication skills
Strong organizational, problem-solving, and analytical skills
Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
Acute attention to detail
Demonstrated ability to plan and organize projects
Proven ability to handle multiple projects and meet deadlines
Working knowledge of data collection, data analysis, evaluation, and scientific method.
Working knowledge and understanding of the basic principles, theories, concepts

Responsibilities

Coordinates product enhancements with customers and internal project teams
Help generate all required documentation in support of the development and manufacturing products and processes, including timelines, responsibilities, engineering protocols, IQ, OQ, PQ reports, bill of materials, assembling instructions, manufacturing instructions and procedures.
Work with quality and supply chain to ensure compliance with QSR and internal protocols.
Review design and determine required Bill of Materials (BOM)
Work with supply chain to obtain BOM pricing (from internal and external vendors)
Support customer calls and presentations to compile product sustaining activities
Provides support in the resolution of product complaints and/or safety issues.
Help to conduct component and device testing methods and protocols.
Identify risks to manufacturing sustainability- provide input to pFMEA and other risk assessment documentation
Works with internal manufacturing as well as outsourced partners to develop metrics such as labor time, yields, statistical analysis, qualification and validation of process, tooling and equipment..
Transfer as required engineering project from engineering into manufacturing.