Project Manager, Research

3 weeks ago


St Paul, United States CareerBuilder Full time

Description
The Research & Development Project Manager will work with a small but seasoned team of medical device professionals responsible for the development and commercialization of the companys next generation products across its wound, burn, and surgery markets. This role oversees design-controlled product development efforts.
This full-time role is located in the Company's Minneapolis, Minnesota, facility and reports to the Project Manager Lead in Research & Product Development (R&PD).
Essential Functions
Oversee and manage design-controlled product development efforts, including definition of proper and testable product requirements, definition of product development milestones, conducting design reviews, and rigorous testing & analysis in support of verification and validation activities
Responsible for the cost, schedule and technical performance of company projects and provide reporting and visibility to SVP of R&PD and executive management
Coordinate the efforts of multidisciplinary teams of internal resources and external partners/subcontractors to successfully execute product development activities
Act as primary customer and supplier contact for project activities, leading project review sessions with internal and external parties to discuss cost, schedule and technical performance
Support business development and proposal activities, as applicable
Other tasks and responsibilities as assigned
Potential Functions, as applicable
Assist with authoring design control documentation such as design verification and validation protocols and reports, design inputs, design outputs, specifications, risk documents, package inserts and regulatory submissions
Lead the design of experiments, including the statistical analysis approach
Requirements
Competencies
Positive, problem-solving approach
Strong work ethic and self-motivation
Demonstrated leadership ability to motivate and guide others to meet objectives and drive actions to closure
Demonstrated ability to interact with multidisciplinary colleagues in a team environment across multiple sites and time zones.
Demonstrated ability to identify, mitigate, and communicate project risks
Proficient organizational skills, including record keeping
Communication skills, both written and spoken, including ability to make compelling presentations
Fluency with Microsoft Project or comparable project management software
Proficiency in Microsoft Office suite
Adherence to deadlines
Adherence to budgets
Knowledge of FDA 510(k)/PMA/De Novo process strongly preferred
Education & Experience
B.S., preferably in a technical field (e.g., Science, Engineering, Design)
Minimum 5-8 years experience in a medical device industry product development role
Minimum 3-4 years in a project management role
PMP certification strongly desired
Experience working in multi-national organizations, preferred
Prior work history in an FDA and/or ISO regulated development environment; specifically 21 CFR 820 and ISO 13485 preferred
Experience with design of experiments, statistical analysis techniques, and data analysis tools, preferred
Anticipated travel: 10%
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time. Kerecis is an equal opportunity employer.

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