Overview
Job Overview: Pay Range: $51.82hr - $56.82hr
Responsibilities
* Collaborate with the R&D and Operations teams in the areas of Design Engineering, Risk Management, Design Controls, Design Verification, Statistical Techniques, Test Method Development, Process Development, Quality Assurance, and Regulatory Compliance.
* Investigate moderately complex manufacturing product quality for all production processes based on engineering principles, analyze results, and make recommendations
* Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
* Lead Risk Management process for project in compliance to appropriate external standards and corporate policies, to ensure critical to quality features are identified and addressed appropriately.
* Responsible for creating and maintaining risk management documentation such as risk management worksheet, FMEAs in alignment with ISO:14971
* Provide integral technical input for the development of project plans, project timelines and strategy to support premarket approval of products.
* Partner with R&D engineers to support design verification/validation strategy and testing, including test method development/validation activities.
* Strong leadership and collaboration with other leaders in project and across the organization
* Mentor engineers in understanding of quality systems and strategies within new product development.
* Support root cause investigations/product evaluations for product failures encountered during clinical use using engineering methods (Six Sigma, DMAIC, etc.)
* Support resolution of manufacturing and compliance issues (i.e. CAPA, non-conformances, audit observations, etc.) utilizing problem solving tools.
* Support Quality Engineering activities to improve customer satisfaction and successful achievement of company quality objectives.
* Responsible for ensuring compliance with all National/Federal, local, and company regulations, policies and procedures.
* Train, coach, and guide lower-level employees on more complex procedures
* Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work.
Skills
* Creativity, verbal and written communication skills, analytical and problem-solving ability.
* Team player and detail-oriented.
* Basic leadership and mentoring skills necessary to provide support and constructive performance feedback.
* Ability to read and interpret blueprints, technical drawing, schematics, and computer-generated reports.
* Previous experience with computer applications and software related to the engineering field, such as Computer Aided Design (CAD).
Education/Experience
* Bachelor's degree in engineering required.
* 5-7 years experience required.
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