This position is responsible for the project management of engineering programs. The specifics of the duties can vary depending upon project deliverables as dictated by the R&D disease state project needs; however will include partnership with cross-functional teams, such as Operations, Marketing, Intellectual Property, Sales, Quality Assurance and Regulatory Affairs, in order to meet project deliverables, including continual improvements to the system working under the direction of the R&D disease state leader.
- Effectively manage and lead project teams in a collaborative environment, completing project deliverables per target timelines and requirements
- Maintain, and monitor project budgets, directing the efficient use of resources to effectively complete projects.
- Oversee project-related activities of project team members, providing guidance on conformance to established design control procedures.
- Identify design problems and make recommendations on raw materials, components, packaging and finished product design and process, providing leadership in the project scope.
- Identify new development procedures, ensuring compliance with all FDA, ISO, GMP, GLP, CE requirements, meeting domestic and international design control regulations.
- Successfully develop and obtain required approvals for design input and design output required documentation working with Product & Brand Management and RA/DA/QA.
- Conduct and/or supervise all design and process validation activities required for assigned projects.
- Provide support and guidance to Clinical Affairs team for physician evaluations, animal studies, and clinical trials required to effectively assess the design of a new product.
- Constantly work to improve the internal systems for design control in order to improve the time-to-market cycle for new products.
- Adhere to all regulatory agency standards, company quality standards and corporate policies.
- The above is not intended to be an all-inclusive list of responsibilities; other activities may be assigned as required by management.
- Demonstrated proficiency in project management or organizational skills.
- Demonstrated experience leading a project in a cross-functional environment.
- Demonstrated flexibility and ability to function in a fast-paced, growth industry and work environment.
- Proficiency in MS Office products, Outlook, Word, Excel, PowerPoint, and Project.
- Excellent communication skills, written and verbal.
- Minimum of a Bachelor degree required, engineering preferred or related technical discipline.
- At least 3 years prior experience in a project management role working in a technical discipline, medical device and/or engineering preferred.