We are looking for a self-starter who likes challenges requiring critical thinking and has keen problem-solving skills. In this role, your work will include activities;
Serve as a core team member on product development teams by providing technical leadership and direction. Responsible for the risk management file, compliance with design control regulation, the completeness and sufficiency of verification and validation activities, and manufacturing quality and validation planning;
Review product and QMS changes for completeness, accuracy, and safety/effectiveness including the identification of all impacts
Identify and initiate product and labeling improvements based on compliant and trending data;
Collaborate with Operations to define and implement systems that enhance efficiency, productivity, and quality;
Provide quality criteria (risk assessment, acceptance criteria, sample size, parameter definition) for validation activities;
Ensure that procedures and processes are maintained and updated to be consistent with regulatory changes including the development of more efficient QMS processes and global QMS processes;
Comply and present quality data in management review;
Generate, maintain and update risk management documentation throughout the life cycle of a product;
Contribute to successful regulatory audits by coordinating back room/front room activities or serving as a subject matter expert;
Perform other duties as may be required by management.
Minimum Qualifications, Skills, and Abilities:
Bachelor’s Degree in Engineering. Mechanical, Electromechanical, Systems, Electrical (with mechanical exposure)
5+ years of experience within the medical device space, R&D, regulatory or design development.
Expertise in scalability of process and product design for growth
Well versed with metrics and data driven approaches leading to quick and efficient adoption of continuous improvement initiatives
Expertise in MDR and Product standard experience.
Experience working with Class II or Class III Medical devices.
Experience working on project teams resulting in PMA and 510k submissions.
Travel requirements: be able to travel to Pittsburgh, PA 1 or 2 weeks a month.