Manager Engineering, NPD Quality

You Will Make an Impact By:

• Leading quality engineering new product development strategy and execution to ensure compliance with global regulatory requirements and a strong culture of quality

• Managing and developing a high-performing team to strengthen business acumen and functional expertise

• Planning and directing operational and project activities, ensuring successful and timely delivery of key deliverables

• Driving continuous improvement by identifying opportunities and leading implementation of process enhancements

• Overseeing engineering activities and providing technical guidance on complex issues and procedures

• Collaborating cross-functionally as the quality engineering lead for a new product development program, including design, development, characterization, verification, validation, and monitoring

• Creating and maintaining complex engineering documentation, including design requirements and risk management documents aligned with design control standards

• Analyzing and resolving complex issues requiring deep technical knowledge

• Supporting additional duties as needed

What You’ll Need (Required):

• Bachelor's degree in engineering, scientific or related field with related experience in engineering

• Experience in quality engineering, quality management, and/or regulatory compliance within the medical device industry 

What Else We Look For (Preferred):

• Demonstrating experience within regulated industries and strong knowledge of FDA, GMP, and ISO/EN requirements

• Experience with product development processes, risk management, and usability engineering.

• Hands on experience with delivery system, sheath and/or catheter design, manufacturing processes, and testing.

• Applying advanced statistical and engineering methods, including DOE, SPC, FMEA, process capability, and Lean Manufacturing

• Leading and developing teams, providing coaching, feedback, and full employee management in partnership with HR

• Managing technical or engineering functions while mentoring peers and influencing cross-functional partners

• Driving successful project execution through strong project management and effective use of metrics

• Applying strong problem-solving, analytical, and critical thinking skills with sound judgment and discretion

• Communicating effectively, producing high-quality documentation, and building strong stakeholder relationships

• Defining and standardizing engineering procedures and team operating practices

• Collaborating with internal teams as well as external suppliers, vendors, and customers

• Presenting technical information clearly to gain alignment and drive objectives

• Managing competing priorities and excelling in a fast-paced, dynamic environment

• Interacting professionally across organizational levels and appropriately escalating issues

• Using Microsoft Office and related systems with a high level of proficiency

• Maintaining strong attention to detail and a high standard of quality

• Building cross-functional relationships to enable best practice sharing and team effectiveness

• Supporting financial awareness as it relates to quality engineering

• Delivering proactive, responsive service to meet client and stakeholder needs

• Adhere to all company rules and requirements (e.g., Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control