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 Function Summary:
Responsible for delivering engineering solutions to sustain production of implantable and consumable medical devices.
- Initiates 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 as appropriate.
- 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 to ensure adequacy of the design requirements and capability of the design to meet the requirements.
- Works cross functionally on design changes, process improvement projects and quality/compliance initiatives.
- Creates and executes protocols for Design Verification and Validation activities, engineering studies and feasibility studies.
- Aids in the selection, design and evaluation of process and test equipment.
- Creates 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.
- Performs product testing and engineering studies.
- Supports the development and revision of part specifications and other design documentation.
- 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.
- Self-motivated, with the ability to accomplish project goals with minimal supervision.
- Experience with Agile PLM and Minitab desired.
- Knowledge of Good Documentation Practices (GDP) desired.
- Bachelor's degree, or equivalent, in Engineering or scientific discipline, such as chemical, biomedical, materials, or mechanical engineering.
- A minimum of two years' experience in the medical device industry with relevant experience in design control, production and process controls and/or R&D or related areas.
- Knowledge of 21 CFR Part 820 and standards relevant to medical devices.
- Strong experience with Microsoft Office applications (Word/Excel/Power Point) is required.
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.
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