Sr. Director, R&D and Engineering

 

 

With a passion for life

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

 

 

 

Job Overview

 

As part of Getinge’s Cardiac Surgery product area, this individual will provide leadership and oversight for all Research and Development (R&D) and Engineering activities. He/She will guide the development of next generation medical devices used in cardiac surgery and ensure efficient and effective new product development and the transfer of new products into production.   He/She will also oversee all aspects of engineering support for commercialized Cardiac Surgery products, including sustaining engineering, process development engineering, and packaging engineering as needed to support the customer and business needs.

 

 

Job Responsibilities and Essential Duties

 

•   Provide leadership, vision, and strategy for the Cardiac Surgery R&D and Engineering functions, in close collaboration with upstream marketing and product management.

•   Direct, monitor and be accountable for adherence to the Product Development Process and         compliance to the Quality Management System with

timely completion of all project management milestones aligned with the Getinge GetAligned PDP processes and the Program Management Office.

•   Collaboratively determines short-term and long-term strategies with design and development projects for new or improved products and/or applications.

•   Works seamlessly with other key functional areas involved in the Product Development Cycle – Product Management, Medical Affairs, Clinical Affairs, QRC, Manufacturing, and

Finance to deliver on business goals.

•   Identifies future technology and intellectual property opportunities that are critical to business growth and leads implementation success to product launch.  Active participant in the due diligence process.

•   Ensures that new product and processing technologies are developed and transferred into supply chain and manufacturing at acceptable quality and yield levels to meet customer and business needs.

•   Interfaces with the Research & Business Development (R&BD) function on pre-studies and other innovation activities.

•   Attend and participate in planned meetings of senior leadership.

• Provide direction to and development of staff through clear communication, goal setting, training, and ownership.

•   Develop an engaged, team-oriented, and empowered workforce with skill and leadership growth opportunities for a strong R&D organization.

•   Ensure product integrity and regulatory compliance in conformance to GMP and ISO Guidelines.

 

Minimum Requirements

 

•   Bachelor’s degree in Engineering, STEM, or other related technical degree. A master’s degree in, Engineering or other related technical degree is preferred.

•   10-15years of experience in medical device, pharmaceutical or other FDA regulated industry required. At least 7 years of progressive leadership experience in research and development and/or engineering is ideal.

 

Required Knowledge, Skills and Abilities

 

•   Must be able to demonstrate effective R&D and leadership skills in inspiring, driving and executing results through others.

•   Must demonstrate and model effective listening, written and verbal communications, sound logical judgment and organizational skills, while at the same time creating in others both a sense of urgency and a commitment to excellence.

•   Must be able to lead within R&D and adjacent functions in the use o