Senior Manager, Design Assurance Engineering
About The Position
Senior Manager, Design Assurance Engineering In this role you As Senior Manager of Design Assurance Quality Engineering, the primary responsibility will be to work within the Quality Management System (QMS) to support the design controls process during development of new medical devices. You will pany policy and procedures to work with supporting team members to analyze situations or data and draw conclusions. Assignments will include creating, reviewing and updating documents, review of product requirements, development of risk management files, auditing Design History Files and actively participating as a core team lead of new product development teams as well as supporting teammates who act as core team leads on new product development projects. The Senior Manager of Design Assurance will also update existing QMS procedures and create new QMS procedures. Your role: Drive engagement within and develop Design Assurance team members. Work with teams and other Design Assurance team members to ensurepliance to the QMS Ensure that NPI projects are adequately staffed and supported. Build stable relationships internally. Manage department to budget. Understand and implement processes and intent of all aspects of the QMS related to Design Controls Using engineering principles, analyze situations or data to identify gaps between project work and QMS. Lead and support Corrective and Preventive Actions (CAPA) and QMS continuous improvement projects Develop mastery of our products and analyzeplaint data, post market surveillance and risk analysis to assist in the identification of potential product improvements based on sound engineering principles You're the right fit if: 8+ years' experience in Quality Assurance, Design Engineering, Systems Engineering, or similar in a highly regulated industry. 5+ years' experience with a MS or higher. 3+ years' experience leading and managing people. New product development experience preferred. Experience with ISO 14971, 21 CR 820, ISO 13485, EU MDR Strong understanding of design quality tools, methods and activities Strong statistical background preferred in reliability / verification, hypothesis testing, sampling, multi-factor analyses Demonstrated expertise in managingplex projects and implementing cultural change. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without amodation for this Office/Remote position.
Requirements
- 8+ years' experience in Quality Assurance, Design Engineering, Systems Engineering, or similar in a highly regulated industry.
- 5+ years' experience with a MS or higher.
- 3+ years' experience leading and managing people.
- Experience with ISO 14971, 21 CR 820, ISO 13485, EU MDR
- Strong understanding of design quality tools, methods and activities
- Demonstrated expertise in managingplex projects and implementing cultural change.
Nice To Haves
- New product development experience preferred.
- Strong statistical background preferred in reliability / verification, hypothesis testing, sampling, multi-factor analyses
Responsibilities
- Work within the Quality Management System (QMS) to support the design controls process during development of new medical devices.
- Analyze situations or data and draw conclusions.
- Creating, reviewing and updating documents, review of product requirements, development of risk management files, auditing Design History Files and actively participating as a core team lead of new product development teams as well as supporting teammates who act as core team leads on new product development projects.
- Update existing QMS procedures and create new QMS procedures.
- Drive engagement within and develop Design Assurance team members.
- Work with teams and other Design Assurance team members to ensurepliance to the QMS
- Ensure that NPI projects are adequately staffed and supported.
- Build stable relationships internally.
- Manage department to budget.
- Understand and implement processes and intent of all aspects of the QMS related to Design Controls
- Using engineering principles, analyze situations or data to identify gaps between project work and QMS.
- Lead and support Corrective and Preventive Actions (CAPA) and QMS continuous improvement projects
- Develop mastery of our products and analyzeplaint data, post market surveillance and risk analysis to assist in the identification of potential product improvements based on sound engineering principles
Benefits
- Employees are eligible to participate in ourprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (withpany contribution), stock purchase plan, education reimbursement and .
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
