Sr. Manager, Design Verification
The Senior Manager, Design Verification plans, supervises and coordinates all design verification activities and resources to ensure that KCI products are thoroughly tested and demonstrated to be safe, reliable, and in compliance with the company's Quality System policies, procedures and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies (as pertains to medical devices). The position also reviews and/or approves process validation and product verification protocols, reports and equipment qualifications. The position utilizes statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), etc.). The position also initiates and/or investigates Corrective and Preventative Actions (CAPA) as appropriate.
This position coordinates overall workflow prioritization and resource utilization of the department, and forecasts resource requirements. The position effectively manages project schedules, workload and resources (internal and external) to prevent erroneous decisions or recommendations. This position requires a strong emphasis on continuous improvement and innovation through new and improved technologies and innovative processes. The position reports to the Senior Director, Engineering Shared Services
- Bachelors degree in Computer, Engineering, or related Sciences field
- Minimum of 5 years experience leading product testing groups
- 5-7 Years of experience managing Design Verification strategies, processes, resources and testing activities in support of new product development and sustaining project requirements.
- Experience with MS Office applications including: Word, Excel, Project, Visio, & Outlook
In addition to the basic qualifications listed above, the following other position qualifications are required:
- Strong test management skills including test and resource planning and project management.
- Familiarity with the Standards, Regulations, and Guidance associated with the development and manufacture of sterile disposable and reusable medical devices.
- Experience condensing complex requirements into specific and measurable test objectives
- Experience identifying and executing capital projects to increase DV lab effectiveness and efficiency
- Experience analyzing data from verification and reliability tests for conformance to pre-determined acceptance criteria and approve formal reports and results summaries
- Experience with engineering/quality statistics and their application; for example, Gauge R&Rs to assess measurement systems, D.O.E.'s to identify significant factors, etc.
- Experience with reliability engineering principles and their application
- Experience with Minitab, Statistical Analysis software
- Ability to apply project management skills to fulfil project requirements
- Demonstrated ability to present technical information effectively to different levels within the organization, including summaries for management and non-technical associates.
- Demonstrated ability to deal effectively with all employees and external business contacts while conveying a positive, service-oriented attitude.
- Demonstrated presentation and communication skills.
- Demonstrated ability to completely maintain confidentiality and discretion in business relationships and exercise sound business judgment
In addition to the basic qualifications and other required qualifications listed above, the following preferred qualifications also exist:
- Masters degree in Engineering or related degree
- Minimum of 5-7 years relevant design control, risk management, design transfer and Quality Management System experience within an FDA regulated industry required.
- Experience with medical device processes in the following areas: Sterilization Validation, Biocompatibility Testing, Package Verification, and Software Verification.
- ASQ certified Manager of Quality/Organizational Excellence Certification - CMQ/OE, ASQ Certified Reliability Engineer (CRE)
- Experience in any of the following test categories: thermal, vibration, HALT, electrical safety (UL/IEC-particularly IEC 6-60601-1), EMC, package testing.
- Technical experience with electrical medical equipment with embedded software controls