This Engineer, Product Sustaining is an active member of the Product Sustaining Engineering Team and provides support by maintaining the design of our existing commercially released medical devices. You will be part of a collaborative cross-functional team to support design and supplier-related changes, corrective and preventive actions (CAPAs), non-conformances (NCRs), product complaints, and other compliance projects for class I and II chest drainage devices and accessory products. The engineer will generate and execute design verification testing, including aging and handling and distribution studies. This role is a balance between documentation and hands-on testing of the product.
Who You Are:
Someone with a background in design and compliance for medical devices and components. You have experience in design and process controls, assessment of design changes, review of and compliance to external standards and regulation. Most likely you have some experience with test method development, product testing, and specification generation. You possess some experience with Design Verification and Design Validation, and change control or have the ability to learn quickly. You enjoy being hands on in testing and redesigning medical devices. Demonstrated analytical, interpersonal, and technical writing skills for the generation of protocols and reports.
You are an individual that is self-driven, possesses a strong desire to learn, strives for excellence, and always keeps quality and the customer in mind in everything you do.
Flexible work hours and options are available; however, the position is expected to have on-site responsibilities performing engineering studies and product testing.
- Bachelor's degree in Engineering or scientific discipline, such as chemical, biomedical, materials, or mechanical engineering.
- A minimum of two years' experience in the medical device industry (or other regulated industry) with relevant experience in design controls, 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/PowerPoint) is required.
Required Knowledge, Skills and Abilities
- Demonstrated ability to solve technical challenges with cross-functional teams.
- Strong analytical and problem solving skills.
- Strong communication and collaboration 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) required.
- Excellent verbal and written communication skills.
- 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.
Environmental/Safety/Physical Work Conditions
- Ensures environmental consciousness and safe practices are exhibited in decisions.
- May work extended hours during peak business cycles.
- This position may require some travel to supplier sites (<10%).
The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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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