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 :
Participates in design changes to improve product performance, reduce cost and enhance the manufacturability of commercially released medical devices.
Supports CAPAs, NCRs and Product Complaints by investigating and addressing potential product design issues.
Maintains the Design History File (DHF) and Device Master Record (DMR) throughout the lifecycle of the product based on changes to the product design or manufacturing process.
Participates in Design Reviews throughout various stages of design development.
Works cross functionally on design changes, process improvement projects and quality/compliance initiatives.
Assists in the creation of reporting of Design Verification and Validation activities, engineering studies and feasibility studies.
Aids in the creation of protocols and reports for process validation, test method validation, equipment qualification and gage R&R studies.
Processes change orders to create or revise design input and output documentation.
Supports the development and revision of part specifications and other design documentation.
Gathers data through testing, inspection and research.
Contributes to the team effort by accomplishing related tasks as needed.
Required Knowledge, Skills and Abilities:
Demonstrated ability to solve technical challenges with cross-functional teams.
Strong analytical, problem solving and communication skills.
Knowledge of Good Documentation Practices (GDP) desired.
Bachelor’s degree in Engineering or scientific discipline, such as chemical, biomedical, materials, or mechanical engineering, or equivalent experience.
One-year of experience in a regulated industry is preferred.
Strong experience with Microsoft Office applications (Word/Excel/PowerPoint) is required.
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.
Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations.
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.
Environmental/Safety/Physical Work Conditions:
Ensures environmental consciousness and safe practices are exhibited in decisions.
May work extended hours during peak business cycles.
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.
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.