Senior NPI Engineer
4 weeks ago
The Senior NPI Engineer will lead the New Product Introduction (NPI) team in providing advanced vision, technology, project leadership, and tooling & equipment expertise to ensure successful product introduction, transfer, and release to production.
Key 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.
- Lead NPI product engineering workflow to ensure that the customer product requirements and specifications are fully understood and fulfilled.
- Collaborate with Cross Functional Molding and Extrusion Centers of Excellence to ensure seamless integration of those workstreams as part of the NPI project subcomponents.
- 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.
Requirements:
- 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.
Work Environment:
100% onsite. 20% travel may be required.
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