Manufacturing Tooling Engineer
Ware has partnered with a medical device with operations in the north metro that is looking for a Manufacturing / Tooling Engineer. In this role, you will work with multiple other facilities on tooling for a highly visible product line. the ideal candidate will have a med device or automotive background, be familiar with designing aesthetically appealing tooling and comfortable working with people over the phone and video conferencing.
- Own and drive quality, continuous improvement, and cost savings initiatives with key suppliers and contract manufacturers in order to assure an uninterrupted supply of the highest quality product at the lowest price with zero production downtime.
-Actively partner with key suppliers, contract manufacturers, and OEMs to resolve technical issues and to develop and complete various levels of raw material and finished device qualifications (primary area of focus for raw materials include: injection molding process/equipment and related tooling and resin processing. Secondary areas of focus are electronics, metals, and chemicals
- Lead projects of moderate complexity associated with component(s) qualification – especially injection molded parts as related to mold design & physical properties of the selected polymer blend.
- Develop a strong relationship with suppliers and act as a partner and advocate in order to resolve technical manufacturing and qualification issues. Adherence to guidance documents for internal & external requirements surrounding Process Development, OQ & PQ qualification runs and MSA activities.
- Develop and maintain strong working relationship with functional stakeholders (R&D, Manufacturing Engineering, Supplier and Operations Quality, Post-Market Quality, Supply Chain, Marketing and Regulatory Affairs).
- Review/prepare test protocols and reports in order to qualify part and product changes.
- Provide technical assistance and guidance to suppliers and contract manufacturers performing qualification and validation testing.
- Implement processes for component qualification that are aligned with company quality requirements, and FDA / ISO regulations and guidelines.
- Drive part and product changes through the Supplier Change Control and Change Order process.
- Provide input into the design, reliability, and manufacturability of new products and coordinate activities within our supplier base. Work closely with component and quality engineers to ensure best practices are horizontally deployed across the value stream.
- Proactively identify opportunities for supplier improvements, and formulate and execute plans to take advantage of those opportunities.
- BS/BA degree in engineering or science with 2+ years of relevant experience. (B.S. or higher in Plastics Engineering highly preferred)
- Experience in a regulated environment (med device, automotive, aerospace)
- Project Management experience
- Injection molding tool design, build and repair
- Rheology knowledge both Crystalline & Amorphous plastics resin (examples include polycarbonate, acrylic, PVC, Nylon and Co-polyesters)
- Understanding of tool steel application for molds for improved operational performance, heat transfer, Rockwell Hardness & welding applications
- Use of Society of Plastics Industry Standards (SPI) for cosmetic acceptance
- Experience working with Contract Manufacturers and OEMs
- Use and understanding of Statistical Tools (Design of Experiments, Measurement System Analysis, Process Capability and Statistical Process Control)
- Development characterization and qualification protocols and reports (including structured DOE evaluation and/or IQ/OQ/PQ/PV documentation)
- Understanding of Geometric Dimensional Tolerancing (GDT) and application for inspection setup and tolerancing allowances of molded components
- Oral, Presentation and Written communication skills
- Minitab, CAD program experience
- Computer Skills (Microsoft Word, Excel, Project, PowerPoint)
EQUAL OPPORTUNITY EMPLOYER
Atterro supports affirmative action and equal employment opportunity. Atterro will provide equal employment in employment practices to all associates and applicants for employment. Employment decisions shall be made without regard to any protected characteristic such as, but not limited to, race, color, religion, gender, age, disability, national origin, ancestry, gender identity, sexual orientation, marital status, status in regard to public assistance, disabled veterans, recently separated veterans, Armed Forces service medal veterans and other protected veterans, genetic information and other legally protected classes. Furthermore, Atterro is an E-Verify employer. Information provided on this application will not be used for any discriminatory purposes. Atterro complies with all applicable federal, state and local non-discrimination laws and regulations. Atterro will provide reasonable accommodations in the application or interviewing process. If you need a reasonable accommodation in the application or interviewing process, please contact us.
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