Senior Product Engineer, Applications

Job Summary

Partner with Engineering and Advanced Operations to define design requirements and develop manufacturing processes to support new product development projects. Lead risk management activities to ensure the highest level of product and process quality.

Key areas of responsibility

• Develop quality assurance documentation to support product transfer, development process, and regulatory submissions.
• Partner with cross-functional project teams to lead product transfer and / or process design and development activities.
• Lead risk management activities for new product transfer and development projects.
• Present risks associated with the product and track the design, documentation, and manufacturing process, to mitigate those issues.
• Partner with cross-functional project teams to define design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.
• Partner with Advanced Operations in the assessment of manufacturing processes for products.
• Develop, review, and approve inspection plans, routers, and product drawings for products.
• Support product design transfers to internal and / or external manufacturing facilities.
• Provide support and direction for other Quality Engineers.
• 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.
• Contribute to the completion of final design verification and validation reports by providing concise conclusions with statistical validity and graphical support.
• Education / work experience (preferred)
• BS in a science, engineering or related discipline.
• MS, CQE, or CRE preferred.
• Six Sigma Green or Black belts are preferred.
• Minimum of 5 years’ experience preferred.
• Experience with medical device product development lifecycle, including risk management, usability, and design / process verification and validation.
• Strong knowledge of Packaging Development / Manufacturing process and related standards
• Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes and Effects Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing / Poke Yoke.
• Demonstrated ability to read and interpret CAD drawings.
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.).
• 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 product excellence and quality.
• Demonstrated ability to effectively work cross-functionally with other departments, including Post-Market, Medical Affairs, R&D, and Regulatory Affairs.
• Strong interpersonal skills, written and oral communication, and negotiation skills.
• Strong in critical thinking and “outside the box” thinking.
• Highly developed problem-solving skills. Strong analytical skills.
• Demonstrated ability to manage and complete projects in a matrix organization successfully.
• Demonstrated ability to work independently.
• Experience in working in a compliance risk situation.
• Product Transfer
• Required Level : II (Target 3-5 years experience)
• Responsibilities
• Change Control
• Sustaining
• Validation

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Job Description : About the role

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As a minimum you must have :

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