Senior Engineer Design Quality

Purpose:

• Develops standard operating procedures, specifications, and provides technical transfer and validation support.

• Minimizes sample and scrap waste, assesses reliability and risks based on validated data, identifies root causes of problems, and reduces or eliminates sources of variation.

• Audits and approves manufacturing, quality, engineering and validation documents for conformance to business practices and departmental procedures. Provides data and documentation in support of the development of validation strategies.

• Acts as liaison to the regulatory affairs department to perform initial regulatory review of all engineering changes and modifications to products.

• Provides sampling plans and approves inspection methods for evaluation and testing of components and products.

• Provides support and expertise in reliability planning and reliability growth demonstration during new product development.

• Support the New Product Development Design Quality Group for the TECA business, mainly for launching orthopedic implants and associated instrumentation.

• Significant contributor to a multi-discipline team in all aspects of the Quality System and provides overall quality assurance leadership in the management of selected contract manufacturing sites engaged in the production of DePuy Synthes products.

• Supports the selected contract manufacturing sites in validation, risk management, product quality issue resolution and escalation, and quality systems performance monitoring for new product development introduction at the manufacturing sites.

You will be responsible for:

• Product development team member focused on product development and life cycle management activities related to the Trauma/CMF business.

• Lead design and development planning activities for new projects.

• Participate in all aspects of the creation and execution of functional/design requirements for new projects.

• Conduct formal technical design reviews throughout the phases of the product development process.

• Support and approve design verification/validation activities including mechanical testing, tolerance analyses, design rationales, and surgeon based anatomical labs.

• Apply statistical methods and design excellence tools to design verification and validation activities.

• Support risk management activities including planning, design & clinical risk management, production risk management, and overall risk benefit reporting.

• Lead the cascade of critical to quality design features to product quality plans and downstream manufacturing & quality processes.

• Support transfer to manufacturing activities both in product development and base businesses.

• Support product life cycle management activities such as design changes and cost improvement initiatives.

• Enhance the design control and risk management processes to better reflect state of the art practices and drive continuous improvement.

• Provide support in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions.

• Understanding of medical device regulations to other disciplines.

• Work closely with suppliers on the qualification of new parts and processes supporting product development.

• Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Product Development, Regulatory, Manufacturing, and Marketing.

• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics, and compliance at all times.

• Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.

• Responsible for communicating business related issues or opportunities to next management level.

• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

• Performs other duties assigned as needed.

Qualifications/Requirements: 

• Education: B.S. in Engineering and/or in a Technical Science

• Minimum of 1 year experience in a GMP and/or ISO regulated industry is required (internships, co-ops, practical experience).

• New product development experience or previous experience in a medical device or a healthcare discipline is preferred.

Preferred:

• Working knowledge of QSR (21 CFR 820) and ISO (13485, 14971) quality requirements is preferred.

• Blueprint literacy including GD&T preferred.

• Knowledge of process and design excellence tools is strongly preferred. Certification is a plus.

• Excellent problem solving, decision-making, and root cause analysis skills.

• Interpersonal skills that foster conflict resolution as it relates to technical situations.

• Embrace teamwork, change, risk-based decision making and flexibility.

• Self-motivated to take action.

• Have excellent written and verbal communication skills.

• New product development experience or previous experience in a medical device or a healthcare discipline is preferred.