Sr Quality Engineer - Exempt

Must Have:
Component Qualification Reports
conducing PPAPs
Injection Molding
Qualification Protocol Writing

Nice to Have:
contract manufacturers

JOB DESCRIPTION
Top 3 technical skills that are required for the role:
Component Qualification reports
Conducting PPAPs
Injection molding

Education Required: Bachelor's Degree or Master's
Years' Experience Required: 4yrs (Bachelor) 2yrs (Master)
Will the contractor be working 40 hours a week? If not, weekly estimate? Yes, 40hrs
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Primarily offsite, with option to be onsite at Grand Rapids site for critical meetings. Primary supplier is also located in Grand Rapids - option for occasional site visits if located in region.
What is your timeline for scheduling interviews? Targeting wk of May 20
What product line will this person support? Cardiac Surgery Cannula and Revasc devices

The *** Molding & Capital Tooling Team is seeking a Senior Quality / Molding Engineer to lead injection molding qualification activities at 3rd party (contract manufacturer) molded component suppliers. Position will support tooling replacement projects as a result of ***'s recent acquisition of a manufacturing site in Grand Rapids, MI.

Experience:
Assist in setting up robust injection molding processes on multi-cavity molds and insert molding
Experienced in the ability to partner and coordinate supplier qualification activities (PPAP, IQ, OQ, PQ, DOE, etc) to meet requirements of the application.
Proficient in generating qualification requirements and reports for injection molded components
Understands limits / fits, tolerance stack up analysis. Highly experienced in Geometric Dimensional Tolerancing (GDT) and application for inspection setup and tolerancing allowances of molded components
Use and understanding of Statistical Tools (Design of Experiments, Measurement System Analysis/Gage R&R, Process Capability and Statistical Process Control)
Experience leader of cross functional teams including R&D, Marketing, Manufacturing, Regulatory, Quality, Sourcing and Supply Chain through qualification processes
Develop and maintain strong working relationship with functional groups (R&D, ME, Quality Operations, Supply Chain and Regulatory)
History of mentoring team members
Skill & Abilities:
Strong organizational skills
Analytical problem solving
Demonstrated initiative and innovation
Ability to transfer the technical knowledge to manufacturing operations
Review/prepare test protocols and reports in order to qualify part and product changes
Work remotely across time zones
Collaborate cross functionally with team members (i.e. R&D, Regulatory, Suppliers/Contract Manufacturers, Marketing, Biocompatibility, and Operations)
Nice to Have:
Experience with contract manufacturers
Solid understanding of Plastic Part Design / Injection Molding Guidelines