Medical Device Program Manager
We are seeking an experienced, high caliber Engineer-Technical Expert to lead process development, validation and process control improvements of Medical Devices.
The successful candidate will have expertise in program and project management in the Medical Device industry. The position requires leading medical device development, process improvement of device assembly and experience in medical device manufacturing. The position will play a key role in supporting projects associated with new and/or legacy products. This position will typically work cross-functionally, driving and collaborating with representatives in R&D, Operations, Quality, Marketing, Clinical, and Regulatory to assure the successful execution of our clients’ business goals.
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.
- Build and maintain relationships with business representatives and stakeholders. Management of KPIs of project delivery to ensure targets are met.
- 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.
- 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 3+ years of Medical Device Engineering experience, OR a master’s degree with 2+ 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.
- 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,
- Basic understanding of statistical techniques. Minitab experience is preferred.