Senior Manager Medical Product Engineering

The Senior Manager Medical Product Engineering is responsible for management of the Pall Medical Product Engineering Team, and the delivery of product lifecycle engineering projects including product changes, VAVE, and the manufacturing transfer and validation of new products. This position reports to the Director Medical Technology and is part of the Product Engineering Team located in Newquay and will be an on-site role. What you will do:

• Manage the prioritization and overall project execution of Product Lifecycle projects across the global Pall Medical product portfolios
• Work closely with R&D, Operations, Product Management, Regulatory and Quality to introduce new products into the market, from manufacturing transfer, through validation to product launch and post launch review
• Implement and sustain visual project management for the high-level plans for projects, supporting teams with identifying bottlenecks and collaborating closely with key partners to resolve scheduling issues, along with overseeing and reporting progress
• Drive clear communication and reporting of critical project progress to leadership teams
• Manage the performance and development of Associates within the Product Engineering Team in support of their professional development and career growth
• Ensure that the Medical Product Engineering Team operates in compliance with the requirements of the relevant ISO standards ISO 9001, ISO 13485, and FDA CFR 820, and the Medical Device Regulations and their revisions.
• Control departmental budget planning and monitoring of planned spending and resource allocation
  
  Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?, Degree in Science or Engineering, or equivalent experience
• At least 8 years' experience of production/process engineering, ideally within the field of consumable medical devices or a similarly regulated industry
• At least 3 years' experience of leading an engineering team through product lifecycle projects
• Understanding and experience of the technical change control validation techniques within the guidelines of an ISO 13485 Quality Management System
• Demonstratable project leadership, data analysis and problem-solving skills
• Competent in prioritizing and managing multiple projects concurrently to time, cost and quality commitments, including the assignment of resources based on business need
• Experience of providing leadership, guidance, and coaching to technical team members, in support of their professional development and career growth
Travel, Motor Vehicle Record:
• Ability to travel - Occasional travel, typically within UK and Europe, although opportunities exist to attend Kaizen events globally
• Must have a valid driver's license with an acceptable driving record
It would be a plus if you also possess previous experience in:
• Good understanding of lean manufacturing principles
• Managing change in a regulated environment
  
  At Cytiva, one of Danaher's (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career. Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible., Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) . Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.