Principal Engineer � Disposables R&D, Sustaining
Principal Engineer � Disposables R&D, Sustaining
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Job Description
Stefanini Group is hiring!
Stefanini is looking for Principal Engineer - Disposables R&D Sustaining in Plymouth MN (Hybrid)
For quick Apply please reach out to Tuhin Podder- call:/email:
Work Hours:M-F (40 hours)
Work Location:Plymouth MN (Hybrid)
Shift:1st Shift
- Technical lead for DHF structure within sustaining engineering for disposable medical devices.
- Manage new 3rd party supplier documentation strategy for peritoneal dialysis disposable sets.
- Manage change controls from initiation through execution.
- Lead the creation and maintenance of design history files.
- Coordinate and communicate the efforts of R&D in collaboration with global cross-functional stakeholders.
- Schedule budget and lead engineering project with minimal guidance.
- Adhere to design control procedures general safety rules company policies and procedures FDA and international regulations and guidance.
Job Requirements:
- BS in Mechanical Plastics Biomedical Engineering or a related field MS preferred.
- 5 - 8 years of related experience in Class II or Class III disposables medical product development.
- Experience in managing medical device product support activities and change controls.
- Experience managing supplier relations & records management.
- Experience managing design output strategies across different product families.
- Experience managing design transfers from R&D to manufacturing.
- Advanced 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.
- Ability to train and coach others from technical expertise.
- Self-directed resourceful and able to manage multiple priorities.
- Strong interpersonal communication collaboration and influencing skills.
- 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
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Required Experience:
Staff IC
Employment Type
Contract
