Engineer � Disposables R&D, Sustaining
Engineer � Disposables R&D, Sustaining
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Stefanini Group is hiring!
Stefanini is looking for Engineer - Disposables R&D Sustaining in Plymouth MN (Hybrid)
For quick Apply please reach out to Vipul Bhardwaj - call:/ email:
Work Hours:M-F (40 hours)
Work Location:Plymouth MN (Hybrid)
Shift:1st Shift
- Create new 3rd party supplier documentation including design specifications labeling design drawings etc. for peritoneal dialysis disposable sets.
- Create modify and maintain design history files.
- Perform change control assessments.
- Work closely with project manager and technical lead to achieve project commitments.
- Adhere to design control procedures general safety rules company policies and procedures FDA and international regulations and guidance.
Qualifications and Expertise:
- BS in Mechanical Plastics Biomedical Engineering or a related field MS preferred.
- Pharma industry background is required.
- 3 - 5 years of related experience in Class II or Class III disposables medical product development.
- Design for Six Sigma (DFSS) training or certification preferred.
- Experience working with external manufacturing partners and supplier relations.
- Experience creating and modifying medical device design outputs including receiving and inspection criteria.
- Experience in medical device product support and change control management.
- Experience in design transfer from R&D to manufacturing.
- Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.
- Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.
- Takes initiative with a high aptitude for learning innovation and implementing best practices and continuous improvements.
- Strong collaboration verbal and written communication skills.
- Strong attention to detail organized and able to independently manage multiple priorities.
- Ability to read write and comprehend English.
Listed salary ranges may vary based on experience qualifications and local market. Also some positions may include bonuses or other incentives.
Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.
About Stefanini Group
The Stefanini Group is a global provider of offshore onshore and near shore outsourcing IT digital consulting systems integration application and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas Europe Africa and Asia and more than four hundred clients across a broad spectrum of markets including financial services manufacturing telecommunications chemical services technology public sector and utilities. Stefanini is a CMM level 5 IT consulting company with a global presence. We are CMM Level 5 company.
#LI-VB1
#LI-HYBRID
Employment Type
Contract
