Stefanini North America and APAC
Engineer – Disposables R&D, Sustaining
Stefanini North America and APAC, Minneapolis, Minnesota, United States, 55447
Overview
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: 2482638630 / email: vipul.bhardwaj@stefanini.com Details
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: 2482638630 / email: vipul.bhardwaj@stefanini.com 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.
Job Requirements
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.
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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: 2482638630 / email: vipul.bhardwaj@stefanini.com Details
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: 2482638630 / email: vipul.bhardwaj@stefanini.com 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.
Job Requirements
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.
#J-18808-Ljbffr