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This role serves R&D in the areas of innovation process deployment and compliance to standards. This includes development and update of procedures, training, coaching, and assessment of the results of project execution of procedures, tools, records, and process audits. Emphasis with this role is on software projects using agile methods and software tools that support the design and development processes.
Your role:
Understand Medical device regulation, design controls, software methods including Agile.
Develop plans to deploy tools and procedures that evolve over time, based on project results and CAPA/audit findings.
Write, edit, and simplify procedures to ensure they are clear, unambiguous, and compliant with applicable regulations, standards, and corporate policies.
Train and coach teams and individuals to execute procedures effectively.
Identify areas to apply tools and automation, including standardized toolsets and application of the Philips Integrated Landscape (PIL) tools.
Observe results of project execution and identify ways to improve the use of processes and tools.
You're the right fit if:
You’ve acquired 10+ years of experience in medical device or similar regulated environment.
Your skills include being an expert user of MS Office tools, Planisware, Clarity, Qlikview, Windchill, SAP, or similar.
You have a Bachelor’s degree in technical area such as engineering, computer science, math, physics.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .
You’re an agent for change, able to develop cultural and innovation change management plans, and work with people and organizational resistance to change.
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
within commuting distance to Pittsburgh, PA
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