Cook Medical Engineering Project Manager in West Lafayette, Indiana
The Engineering Project Manager will ensure projects are executed per approved project plans, budgets, and in compliance with the Cook Biotech quality system. The EPM will strive for excellence in project management, will be responsible for determining resources needed to accomplish project, serve as a subject matter expert, and act as a key contributor to the execution of project deliverables. The EPM will also be responsible for developing contingency plans to deal with high risk project elements and revising project timelines/activities should risks be actualized. The EPM will exhibit a high level of detail to all project deliverables to ensure they are completed accurately, comprehensively, and as intended. Primary areas of responsibility include design changes, regulatory responses, risk management activities, design verification and validation, feasibility testing, and maintaining DHF and RMF documentation in accordance with Quality System documents.
Essential Job Function/Duties:
Areas of Responsibility
- Responsible for managing multiple projects and sub-projects related to the primary functional areas listed above.
Demonstrated knowledge of Cook Biotech Quality Systems.
Demonstrated experience in applying ISO 13485 and ISO 14971 principles for executing job responsibilities.
Demonstrated ability to identify and apply external standards as required for the job function.
Demonstrated ability to lead project across the entire lifecycle.
Uses experience and judgement to recommend path forward.
Consults with senior team members and supervisor for decisions as needed.
Communicate with persons across the Company and its partners, to understand the needs of each and to provide the resources to meet those needs within the scope of a project.
Manage the assignment and execution of project deliverables across the functional team.
Works with the local team and has become established as a collaborator with other functional areas.
Identities and records improvement opportunities.
Identifies improvement opportunities within the Quality System.
Submits change orders for Quality System improvements.
Submits invention disclosures with other team members.
- B.S in Engineering (Biomedical or Chemical preferred), or related scientific field.
- Minimum 5 years of experience as a project engineer, project manager, or development engineer in medical device product development role.
Excellent understanding and experience in Medical Device development quality systems.
Ability to design and execute experiments intended to support feasibility and development efforts.
Excellent documentation skills with the ability to appropriately record laboratory activities.
Able to write laboratory protocols and reports, as well as perform data analysis.
Experience with application of statistical methods (t-test, ANOVA, Gage R&R, tolerance intervals, etc.).
Excellent task and time management skills with the ability to manage and work on multiple projects simultaneously.
Able to effectively communicate task status and project updates to team members, management, and other stakeholders.
Able to receive and appropriately act upon ideas, suggestions, and feedback
Sufficient background to generally understand medical and biotechnology terminology.
Consistent attention to detail.
- Minimal (<10%)
Posting Date1 month ago(1/17/2020 12:11 PM)
Job Location(s)West Lafayette IN United States
Position TypeFull Time
CompanyCook Biotech Inc.