Flexan
Principal NPI Engineer
Flexan, Salt Lake City, Utah, United States, 84193
JOB DESCRIPTION:The Principal NPI (New Product Introduction) Engineer is responsible for providing our New Product Introduction Engineering team with the advanced vision, technology, project leadership, and tooling & equipment expertise they need through the entire product introduction, transfer and release to production process. This role will provide for project and technology leadership alongside talented engineers, technicians, and technical writers through the entire accelerated NPI process, from customer's design requirements, new product introduction, transfer to manufacturing process engineering, as well as lean & continuous improvement initiatives throughout product fulfillment meeting customer's requirements.
KEY ROLE AND RESPONSIBILITIES:
Promote safety through leadership in process safety analysis, ergonomic assessments, and process improvement activities.Provide senior leadership on NPI Projects and amongst the NPI engineering department, on new product introduction process in all Tooling and Equipment Specification, and validation IQ, OQ and PQ stages, including engineering support for mass production.Work independently or with only consultative direction toward long-range goals and objectives.Lead NPI product engineering workflow to ensure that the customer product requirements and specifications are fully understood and fulfilled and that the initial control of product engineering changes are fully documented and deployed on the production floor, and that the bill of material is fully validated.Lead NPI Project industrial engineering workflow to ensure the completion of Process Flow, Time Studies, Capacity Analysis and Labor Content Determination, and determining the Standard Hours to complete the plant / company Quote Process.Collaborate with Cross Functional Molding and Extrusion Centers of Excellence to ensure seamless integration of those workstreams as part of the NPI project subcomponents.Lead NPI Project equipment design workflow, performing as a minimum the Validation and Qualification Customer Mechanical Assemblies, Review of required Equipment, Material, and Customer Dimensional, Functional and Cosmetic Requirements, then Conduct Equipment Design Review, and subsequently Approve the Equipment release to Manufacturing. Responsible for TPM of tools/fixtures, and relationship with their vendors through IQMS or database.Utilize lean process technology and automation during NPI execution to continuously improve the manufacturing environments driving cost leadership, world class quality, and customer satisfaction.Plan, implement, and execute complex engineering projects, including defining the project philosophy, activities, milestones, and staff requirements per customer requirements.Evaluate and select equipment to support process upgrades and new product introductions.Serve as an advisor to management and customers on advanced technical processes and applications and in the assessment of new opportunities.Hands on, Lead without authority by example. Be hands on providing mentoring and training to the Engineering team for growth.Demonstrate all of Flexan’s corporate values:We have an engaged culture.We embrace the rigor to be safety and quality driven in all we do.We embrace the choice to work here.We operate with transparency, ethics, and integrity.We consistently meet our expectations.Minimum Qualifications:
Experience working in Medical Device Manufacturing industry preferred.Bachelor of Science in Engineering or related field.Typically 12+ years of relevant experience or a combination of equivalent education and experience.Recent related experience in a manufacturing environment.Thorough knowledge of ISO 13485 and FDA Quality System requirements.Knowledge of financial, sales and marketing as related to development and manufacturing.Solid understanding of current software, tooling and mechanical engineering issues and needs.Demonstrated ability to manage projects, polymer processing and equipment, and mechanical design.Physical Demands:
Occasional lifting to 50 lbs.Work Environment:
100% onsite.20% travel may be required.
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KEY ROLE AND RESPONSIBILITIES:
Promote safety through leadership in process safety analysis, ergonomic assessments, and process improvement activities.Provide senior leadership on NPI Projects and amongst the NPI engineering department, on new product introduction process in all Tooling and Equipment Specification, and validation IQ, OQ and PQ stages, including engineering support for mass production.Work independently or with only consultative direction toward long-range goals and objectives.Lead NPI product engineering workflow to ensure that the customer product requirements and specifications are fully understood and fulfilled and that the initial control of product engineering changes are fully documented and deployed on the production floor, and that the bill of material is fully validated.Lead NPI Project industrial engineering workflow to ensure the completion of Process Flow, Time Studies, Capacity Analysis and Labor Content Determination, and determining the Standard Hours to complete the plant / company Quote Process.Collaborate with Cross Functional Molding and Extrusion Centers of Excellence to ensure seamless integration of those workstreams as part of the NPI project subcomponents.Lead NPI Project equipment design workflow, performing as a minimum the Validation and Qualification Customer Mechanical Assemblies, Review of required Equipment, Material, and Customer Dimensional, Functional and Cosmetic Requirements, then Conduct Equipment Design Review, and subsequently Approve the Equipment release to Manufacturing. Responsible for TPM of tools/fixtures, and relationship with their vendors through IQMS or database.Utilize lean process technology and automation during NPI execution to continuously improve the manufacturing environments driving cost leadership, world class quality, and customer satisfaction.Plan, implement, and execute complex engineering projects, including defining the project philosophy, activities, milestones, and staff requirements per customer requirements.Evaluate and select equipment to support process upgrades and new product introductions.Serve as an advisor to management and customers on advanced technical processes and applications and in the assessment of new opportunities.Hands on, Lead without authority by example. Be hands on providing mentoring and training to the Engineering team for growth.Demonstrate all of Flexan’s corporate values:We have an engaged culture.We embrace the rigor to be safety and quality driven in all we do.We embrace the choice to work here.We operate with transparency, ethics, and integrity.We consistently meet our expectations.Minimum Qualifications:
Experience working in Medical Device Manufacturing industry preferred.Bachelor of Science in Engineering or related field.Typically 12+ years of relevant experience or a combination of equivalent education and experience.Recent related experience in a manufacturing environment.Thorough knowledge of ISO 13485 and FDA Quality System requirements.Knowledge of financial, sales and marketing as related to development and manufacturing.Solid understanding of current software, tooling and mechanical engineering issues and needs.Demonstrated ability to manage projects, polymer processing and equipment, and mechanical design.Physical Demands:
Occasional lifting to 50 lbs.Work Environment:
100% onsite.20% travel may be required.
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