SearchPros
Sustaining Systems Design Quality Engineer II
SearchPros, Osseo, Minnesota, United States, 55311
Description: Hybrid - 3 days onsite, Maple Grove. Seeking a Sustaining Systems Design Quality Engineer II in our Maple Grove, MN location. This is an exciting opportunity to participate in the quality assurance of our medical electrical equipment/systems (MEE) within Interventional Cardiology (IC). The Design Quality Engineer II will support application of design controls to projects focusing on design changes, material continuity, regulatory and standards compliance, corrective and preventive actions, and improvements for manufacturability and cost reduction. This individual will work with a high performance cross-functional team to ensure safety, quality, and compliance of products.
Responsibilities
Ownership of design change projects including scoping, assessment, and implementation. Develop, update, and maintain Design History File and Design Input / Output documentation Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA. Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements. Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Qualifications
3-5 Years with BS. Degree must be clearly stated on resume. Bachelor’s degree in mechanical, electrical, or biomedical engineering, highly preferred Experience with design control, risk management, and medical device standards compliance Experience with corrective and preventive action Adaptable and effective collaborator in a team environment and in self-directed work Strong communication skills (verbal & written) Need: Hazard analysis, risk controls, DFMEA, complaint analysis, NCEP/CAPA experience; design quality experience – not just manufacturing quality. Ability to pass Background, Drug Screen and if applicable Medical (i.e. Vision, Hearing, or Physical) if Required by Client. Medical, dental, vision, ancillary coverage and 401k benefits are available.
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Ownership of design change projects including scoping, assessment, and implementation. Develop, update, and maintain Design History File and Design Input / Output documentation Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA. Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements. Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Qualifications
3-5 Years with BS. Degree must be clearly stated on resume. Bachelor’s degree in mechanical, electrical, or biomedical engineering, highly preferred Experience with design control, risk management, and medical device standards compliance Experience with corrective and preventive action Adaptable and effective collaborator in a team environment and in self-directed work Strong communication skills (verbal & written) Need: Hazard analysis, risk controls, DFMEA, complaint analysis, NCEP/CAPA experience; design quality experience – not just manufacturing quality. Ability to pass Background, Drug Screen and if applicable Medical (i.e. Vision, Hearing, or Physical) if Required by Client. Medical, dental, vision, ancillary coverage and 401k benefits are available.
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