Job Responsibilities and Essential Duties
- Apply sound technical and business principles to define new product development projects.
- Effectively and efficiently manage the activities of cross functional product development teams in the design and development of medical devices, components and technologies from concept to commercial product launch.
- Serve as program leader and manage cross functional program resources. Coordinate and run team meetings. Prepare and give oral presentations in a group setting. Directly interact with supporting functional groups (Regulatory, Quality Engineering, Manufacturing, Engineering, Marketing, and Quality Control) to meet project objectives and keep programs on track.
- Generate project status reports and presentations as required. Present progress with senior/executive management.
- Prepare and submit project plans and budgets, which identify milestones and resources, and track project timelines and costs.
- Ensure regulatory compliance in product development, including coordinating design control activities.
- Identify project and timeline risks and develop risk mitigation strategies.
- Manage unexpected program delays and direct cross-functional team efforts to re-align with established project timelines.
- Participate in negotiation of business transactions with outside parties.
- Contribute to the team effort by accomplishing related tasks as necessary.
Minimum Requirements
- Bachelors or Master's Degree in technical field. An engineering degree is desirable.
- A minimum of seven years of relevant experience developing medical products with a minimum of three years' experience in project or program management.
- Knowledge of Quality Systems, ISO, GLP, GMP and FDA requirements.
- Experience in surgical and interventional medical device design is highly desirable.
- 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 handle multiple projects and effectively manage timelines.
- Demonstrated analytical and problem solving skills.
- Demonstrated strong technical skills, including technical writing experience.
- 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.
- Strong skills with MS Office applications are required (Word, Excel, Powerpoint and Project).
Internal and External Contacts / Relationships
- Provide examples of internal and external relationships to this position.
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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