Job Purpose :
As a key part of the strategic leadership team of the of Getinge's Cardiac Assist (CA) product area, this individual will provide leadership and oversight for all Engineering and New Product Development activities across the hardware, disposables and the OEM businesses. He/she will help define the business objectives, growth and strategic product development goals for the CA Product Area. He/She will assure the timely delivery of next generation medical devices and ensure efficient and effective commercialization and transfer of new products into production. He/she will assure the timely delivery of projects led by the Engineering departments to support products in market to assure they are completed and implemented in a thorough and efficient manner.
• Provide leadership, vision, and strategy for the Cardiac Assist Engineering and New Product Development functions.
• Direct, monitor and be accountable for compliance to the Product Development Process (Design Control) and the timely completion of all project management milestones aligned with the Getinge GetAligned PDP processes and ACT Program Office.
• Drive collaboration and alignment across the Global Getinge engineering and new product development teams as well as external engineering resources.
• Develop engineering talent across the team and allocate resources as needed to meet CA product area and department's objectives.
• Maintain close affiliation with other key functional areas involved in the Product Development Cycle – Marketing, Clinic, Sales, QA/RA Service, Operations and Finance.
• Collaboratively determines short and long term strategies and projects for the investigation, design, and implementation of new or improved products and/or applications as well as support product care projects as needed for products in market.
• Identifies future technology and intellectual property critical to future business growth and drives implementation. Active participant in the due diligence process.
• Ensures that new product and processing technologies are developed and transferred into manufacturing at acceptable quality and yield levels.
• Coordinate the processing of Change Notices assigned to the department. Use resources of the department to obtain full understanding of why change is required, develop solutions and authorize change through sign-off procedures. Provide follow-up to assure changes are implemented and successful.
• Lead multi-discipline Corrective Action Team to identify product and system problems and assure appropriate resources are assigned to resolve the issues in a timely manner. Provide follow-up to assure changes are implemented and are successful.
• Provide direction to and development of staff through clear communication, goal setting, training, and ownership.
• Develop an increasingly-participative, team-oriented and empowered workforce.
• Drive efficiency improvements and cost savings initiatives.
• Ensure product integrity and regulatory compliance through Quality and Regulatory operations and conformance to GMP and ISO Guidelines.
Required Knowledge, Skills and Abilities:
• Must be able to demonstrate effective leadership skills in creating trust, 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 others in the use of critical thinking, problem solving and analysis tools, and be able to coach others to execute superior technical project leadership. Experience in utilizing Six Sigma tools such as DMAIC is ideal.
• Must be able to lead others in the use of statistical experimental design and analysis techniques. Working knowledge of Design of Experiments (DOE) or equivalent analysis techniques is preferred.
• Experience working with Lean or other manufacturing excellence tools is preferred.
• Bachelor's and Master's degree in Business Management, Engineering, or other related technical degree required.
• 7-10 years of experience in medical device, pharmaceutical or other FDA regulated industry required. At least 5-7 years of progressive leadership experience in operations, engineering, and/or product development is ideal.
• Experience within Medical Tech industry as well as other regulated industries preferred.
• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
• Attend all required Quality & Compliance training at the specified interval.
• Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.
Environmental/Safety/Physical Work Conditions:
• Responsible for understanding and conforming with the Environmental Policy to ensure that significant environmental aspects that relate to actual or potential impacts with their work are executed to minimized the effects on the environment.
• Responsible for bringing to the attention of management any potential improvements that could reduce our environmental impact or to report activities that could result in a negative impact to the environment.
• Responsible for understanding and conforming with the Health and Safety Policy to ensure that the significant risks that relate to actual or potential hazards with their work are identified.
• Occasional travel to sister corporate offices, suppliers, and outside laboratories (~10%)
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.
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