Coordinate and manage the activities of cross functional product development teams in the design and development of medical devices and components from concept to commercial product launch, and in ongoing support activities of existing products.
Serve as Project Leader and manage cross functional project resources.
Coordinate and run cross-functional project team meetings, both in-house and with contract resources. Directly interact with supporting functional groups (Regulatory, Quality Engineering, Manufacturing, Engineering, Marketing, and Quality Control) to meet project objectives and keep projects on track.
Develop, document and manage project plans, timelines and budgets with support of Program Manager/ PM Group Manager as needed.
Assist in identifying project and timeline risks and develop risk mitigation strategies.
Assist in ensuring regulatory compliance in product development, including coordinating design control activities.
Generate project status reports and presentations as required.
Review project progress with senior/executive management.
Manage unexpected program delays and direct cross-functional team efforts to re-align with established project timelines.
Contribute technically to projects as required.
Assist in developing vendor contracts and specifications.
Assist in special projects as needed.
Contribute to team effort by accomplishing related duties as requested.
Minimum Requirements
Bachelors or Master's Degree in technical field.
A minimum of three years of relevant experience developing medical products with a minimum of one year experience in project or program management.
Agile PLM and Oracle experience preferred
Required Knowledge, Skills and Abilities
Working knowledge of medical device industry, FDA regulations, quality systems and design control.
Experience leading the development and implementation of projects, with ability to concurrently manage multiple small to mid-sized projects and associated timelines.
Demonstrated analytical and problem solving skills.
Ability to work independently, as well as effectively interact and communicate with all levels of the organization in a team environment.
Proficient oral and written communication skills; technical writing experience.
Strong experience with MS Office applications is required (Word/Excel/Powerpoint/Project).
Quality Requirements
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
Attend all required Quality & Compliance training at the specified interval.
Adopt the "Beyond Compliance Quality Culture" in the work environment; always meet and exceed requirements.
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.
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We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world's most desired medtech company.