Department: Azzur of CA, LLC
Key Responsibilities May Include:
- Program manager and technical leader for a team of engineers and cross-functional representatives in design, development, and commercialization of Class I, II & III medical devices. Drive the creation of project plans and critical paths, allocation of project teams, tasks, and responsibilities.
- Lead, manage and direct the development and execution of integrated project plans relevant to the deliverables and ensure alignment across relevant functions and a smooth transition among pipelines stages.
- Drive the medical device product development process through all phases of its lifecycle, from concept to delivery and post-market surveillance. Review feasibility of projects and ensure projects are in line with organizational strategic plans.
- Build and maintain relationships with business representatives and stakeholders. Management of KPIs of project delivery to ensure targets are met.
- Facilitate the testing and/or improvement of products by championing the development of complex experiments and tests (including writing and executing protocols), analyzing results, driving team recommendations, and developing reports, based on engineering principles.
- Leading process development efforts as required including the characterization and validation of devices and sub-assemblies.
- Production and review of design drawings and specification documents.
- Develop teams to conduct experiments and DOEs to assess and demonstrate product/process/system performance.
- Ensure proper procedures and documentation practices are in place to support equipment selection, tooling and fixture development, procurement, installation, and qualification.
- Facilitate activities in support of designing, building, and executing testing of components or sub-assemblies, document, and present test plans to broader audience of stakeholders.
- Ensure all aspects of the product development life cycle meet regulatory expectations for design controls (ISO 13485, FDA 21 CFR 830.30); lead design reviews and ensure on-time completion of Design Control deliverables.
- Prepare risk management files and identify mitigations, drive risk management activities from product conception through commercialization.
- Manage supplier quality requirements while ensuring internal and external suppliers are meeting expected timelines, delivery schedules and costs.
- Coordinate and manage transfers of new device assembly requirements to manufacturing with hands-on technical support, including developing Six Sigma processes/documentation for routine clinical and/or commercial production.
- Implement process improvement strategies to improve quality, reliability, and/or reduce cost.
Required Education & Experience:
- BS/MS in Mechanical Engineering, Biomedical Engineering, Chemical/Biochemical Engineering.
- Bachelor's degree with 8+ years of Medical Device Engineering experience, OR a master’s degree with 7+ years of Medical Device Engineering experience.
- Knowledgeable medical device standards such as ISO 13485 and CFR 830.30. Follow policies, processes, and procedures in the quality system.
- Experienced in all facets of project management methodology including the generation and maintenance of Gantt Charts. Expertise in MS Project is preferred. PMP certification desired.
- Proven track record of successful collaboration and leadership to cross-functional teams to advance complex projects to completion. Excellent organizational, leadership, teamwork, written and verbal communication skills together with demonstrated ability to work in a highly matrixed team environment with enthusiasm and a proactive, positive attitude.
- Proven problem-solving, analytical and critical thinking skills.
- Experience with Six Sigma, DMAIC, and risk analysis methodologies, process characterization, process validation and process monitoring, scale-up, and/or technology transfer experience, pFMEA, dFMEA, and hazard analysis.
Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.