Principal Product Engineer - Integrity Testing

Pall ,
Braunton, Devon
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Job Description

Find what drives you on a team with a 70+ year history of being recognized for discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers protect people. Our portfolio is broad, so if your interests lie along the spectrum of Life Sciences to Industrial, you'll find a rewarding role here. Our career opportunities are as diverse as our products and they are all focused on creating better lives and a better planet. At Pall, we believe that innovation is our legacy, our privilege, and our destiny. If that resonates with you, join us! Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years. At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team. Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive. SUMMARY PURPOSE OF THE POSITION: Great opportunity to the Principal domain specialist at this key Biotechnology manufacturing site! To support the Biotech PE group in the technical aspects of Product Life Cycle Management (PLCM) (NPI, Sustaining, Process Improvements) including both Biotech products and Biotech specific process as. To support Biotech on the resolution of technical issues and to approve non-conformances in a technical capacity. The job holder will also be responsible for a project portfolios, timelines and design authority. MAIN DUTIES: Control a project portfolio within a small Engineering team (with or without direct reports). Act as the domain expert/design authority for product portfolios or critical processes/equipment. Interpret external/internal guidelines and develop solutions. May be responsible for day to day management of small Engineering team. Be responsible for resolution of complex technical problems and approval within corporate non-conformance system with minimal supervision or guidance. Provide technical leadership during customer audit. Introduce new Filtration Equipment & processes to Pall Ilfracombe by team working with R&D , Marketing and Manufacturing. Provide Stage progress reports on New Process development and organise development batches on filter manufacturing shop floor. Write detailed validation protocols for FAT, IQ, OQ, PQ as and when required. Execute validation protocols as above. Collate and provide quality performance data in support of new product introductions. Calculate process costs. Collaborate closely with suppliers of materials and equipment. Run own project "focus team meetings " on new products - be prepared to present details from manufacturing to senior executives. Solve problems related to new products by using 6 sigma tools, trend analysis, Design of Experiments , FMEA , process risk assessments etc. Control and retention of all Equipment Design Documents. Provide technical support for site in relation to customer issues and non-conformance. Able to travel in UK, Europe and USA. REQUIRED QUALIFICATIONS / EXPERIENCE: A recognised Engineering Certificate/Degree or equivalent and subsequent experience in Product Engineering. Any formal training and qualification in Six Sigma techniques would be an advantage. Product design experience with at least part in a medical device or Bio-Pharmaceutical Manufacturing Industry. Additional experience within an R&D environment would be a valuable asset. Engineering team management; including project allocation, PDP and mentoring. KNOWLEDGE / KEY SKILLS: Knowledge of Process validation procedures and techniques e.g. Process and product FMEA, Ishikawa diagrams, Pareto analysis, parts and process capability studies. Able to write Factory Acceptance Tests, IQ, OQ and PQ documents for new processes and equipment as required. Proficient in IT practices and experience of common Microsoft applications. Ability to work as a team leader towards completion of a portfolio of new process projects and technical issue resolution. Able t

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