Medical Device Project Manager
An ideal candidate for our Medical Device Project Manager will be responsible for driving multiple products and projects through the entire life cycle, including 510 submittal. The right individual will need to manage both internal and external expectations, adjust to changing priorities/environments while meeting deadlines, and identify risks within the project. The candidate will need to preform productively under tight timelines, have strong communication skills, and work well in a fast paced environment.
- Serve as the Project Manager of Canfield’s Medical Device Initiative organizing and coordinating the various activities (both internally and with external consultants as needed) to become Medical Device ready in the USA, EU, Australia, and other territories
- Lead the Medical Device team to define milestones, achieve timeline commitments, and identify risks and issues
- Collaborate with SMEs and Quality Assurance to develop and/or review Medical Device deliverables
- Establish a communication strategy in which to keep all stakeholders and management current on project tasks, their owners, status, roadblocks/issues
- With other stakeholders (external consultants as needed) support the Exact-Transform-Load (ETL) testing efforts associated with applicable standards (60601 and others)
- Develop mechanisms for monitoring project progress and for intervention/problem solving with the team.
- Monitor updates to applicable standards and regulations
- Work with Quality Assurance to ensure project is compliant with regulations
- Prepare and lead management review meetings with agendas, minutes, and action items while facilitating risk management of projects and escalation/mitigation of significant deviations
- Bachelor of science degree in engineering or equivalent and at least 5 years’ of experience as a project manager
- Strong leadership, project management, organizational skills
- Knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304 and other international standards and country/region-specific medical directives as well as FDA applicable regulations
- Experience in 21 CFR Part 11 regulated software
- Background in quality, mechanical, or electrical engineering
Founded in 1987, Canfield Scientific, Inc. is a core imaging lab providing custom photographic systems, image monitoring, and centralized analysis services for the pharmaceutical, biotechnology and cosmetics industries supporting global clinical trials providing primary endpoint data and supporting documentation. Canfield has supported over 2,000 clinical studies, worked worldwide with thousands of clinical study sites, and has been retained by many of the world's leading biotechnology and pharmaceutical companies. Canfield's imaging equipment leads the industry providing high-quality, registered, reproducible clinical images. This, together with proactive clinical image monitoring and a world class quality assurance regimen, sets the gold standard in image quality for clinical studies.