Together we can make a difference
At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope – just to name a few.
A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.
Job Functions: (Primary “essential” duties and responsibilities)
- Classify/separate design input vs. output requirements in derived requirements documents
- Evaluate the potential restructuring and release of algorithmic “white papers”
- Update and maintain proper design output documentation: including low level software implementation requirements (white paper design outputs), traceability matrices, and output verification testing
- Develop and implement system-level design verification and validation concepts
- Re-execute verification/validation test protocols, as deemed necessary
- Work with cross-functional teams, in a team-member role, to ensure the timely release of project critical deliverables
- Post-market surveillance risk process upgrades
Required Skills and Abilities:
- Strong problem-solving, design, and technical skills
- Strong test execution and data acquisition/analysis skills
- Highly adaptable individual that can quickly learn new areas of remediation
- Excellent interpersonal, verbal, and written communication skills
- Detail oriented work habits
- Well organized
- Knowledge of design verification and validation concepts, including the planning and execution of system-level testing of medical devices
- Ability to be a contributing member of cross-functional development teams
- Task oriented and driven to complete assignments on schedule
- Medical Device experience, including a thorough understanding of Design Control and Risk Management
- Knowledge of requirements development, classification, traceability, and the implementation process
- Working knowledge of FDA and International Standards requirements pertaining to capital equipment
- Knowledge of medical device risk management, including ISO 14971:2012
- Experience with Requirements Management Tools (i.e.: CaliberRM)
- Experience with Quality Management Document Control Systems (i.e.: TrackWise)
- B.S. in Biomedical, Electrical, or Software Engineering with 3+ years of related experience
- M.S. in Biomedical, Electrical, or Software Engineering with 2+ years of related experience
This is a “Defined Term” assignment that will last approximately 12 months or until project is complete. Defined Term employees are eligible for most Getinge benefits (including health insurance and vacation time) while on assignment.
Getinge Group 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.
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.