Position – Design Assurance Lab – Supervisor
Boston Scientific Corporation
- The R&D DA Lab Supervisor will be a part of the R&D quality organization and lead the Design Assurance (DA) Lab . The individual will be responsible to set up, control and maintain the design assurance lab and supervise the activities of personnel in the design assurance lab area. Ensure that daily testing schedules are met, and that testing standards and procedures are followed. Establish and support a work environment of continuous improvement that supports the appropriate regulations for testing.
- The individual will also be responsible for assuring all requirements for the Product Development Process (PDP) design verification and validation are met by: a.) Providing quality and compliance input to the project team for project decisions and deliverables (e.g. Master Verification and Validation Plan, Test Methods, Design Verification and Validation, Usability Testing) whether internal, co – developed or externally manufactured, b.) Providing quality and compliance input and coaching for Product Verification and Validation, and c.) Supporting corporate quality initiatives utilizing their PDP, Design Control, and Verification and Validation expertise.
- The individual should be a team player who is willing to collaborate and work in cross functional teams across geographies and cultures and should be comfortable working in a matrix organizational structure.
Qualifications & Experience
- Bachelor s in engineering with preference mechanical engineering, plastics, and polymer engineering and reliability.
- 10+ years of engineering experience and at least 5 years of experience in medical device R&D engineering.
- Past experience in managing medical device labs will be an added advantage.
- Professional training and certification in Quality Management Systems including ISO 13485, Testing and Calibration ISO17025, Risk management ISO 14971, design assurance/control, and CAPA/NCEP management.
- Experience working in a highly regulated environment and a sound understanding of medical device regulatory requirements for Class II and III medical devices.
- Well versed with statistical analytical techniques and s/w tools like MINITAB.
- Preference for candidates with PMP certification or similar project management training and experience resourcing, timeliness, quality, and budgets.