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Responsibilities:

• Develop quality assurance documentation to support new product development process and regulatory submissions.
• Support quality system maintenance for the design control process by identifying and correcting deficiencies in procedures and practices.
• Engage in the design, development, manufacturing, and risk management activities for new product development projects. Engage in design reviews by identifying risks associated with the product used and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
• Support risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.
• Participate in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
• Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria.
• Contribute to the completion of final design verification and validation reports by providing concise conclusions with statistical validity and graphical support.
• Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits, establish process parameters, resolve quality problems, etc.
• Develop, review, and approve inspection plans, routers, and product drawings for new products.
• Support product design transfers to internal and/or external manufacturing facilities.
• Evaluate predicate products for relevant quality issues that may impact new product development projects.
• Analyze and define critical quality attributes for product and process through risk analysis techniques.
• Participate in collection of initial market feedback on new products and address early concerns.
• Engage in the evaluation of overall residual risk for products prior to launch and present final risk/benefit justification to executive leadership.

• Bachelor's Degree in Engineering
• 2 years of related experience , including experience in a regulated industry such as medical device, automotive, aerospace or electronics
• Bachelor's Degree in Software Engineering, Electrical Engineering, or Computer Science Engineering highly preferred
• Human factors engineering experience preferred
• Software development life cycle and ability to establish software testing protocols and evaluate software code preferred
• Experience with PPAP in relation to electrical components such as wiring harnesses, PCBA, displays, actuators and motors preferred
• MS, CQE, or CRE preferred.
• Six Sigma Green or Black belt preferred. Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation.
• Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
• Demonstrated ability to read and interpret CAD drawings.
• Thorough knowledge and understanding of US and International Medical Device Regulations.
• Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
• Must possess strong project management skills as well as have the ability to manage multiple tasks simultaneously.
• Demonstrated ability to advocate for product excellence and quality. Demonstrated ability to effectively work cross-functionally with other departments, including Advanced Operations, Product Development, Regulatory Affairs, and Marketing.
• Strong interpersonal skills, written, oral communication and negotiations skills.
• Strong in critical thinking and "outside the box " thinking.
• Highly developed problem-solving skills. Strong analytical skills.
• Demonstrated ability to successfully manage and complete projects in a matrix organization.
• Demonstrated ability to work independently.
• Experience in working in a compliance risk situation.
• Computer literacy (including proficiency with Mini-Tab or similar analysis program).
• Some travel may be required.