Principal Engineer â Disposables R&D, Sustaining - Hybrid
Principal Engineer â Disposables R&D, Sustaining - Hybrid
Posted on :
14-07-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
For further inquiries regarding the following opportunity please contact our Talent Specialist:
Hema at
Title: Principal Engineer Disposables R&D Sustaining - Hybrid
Location: Plymouth MN
Duration: 12 Months
This project will run through 12/2026
Workers can be remote/hybrid but must be local and able to come into the office at least three days a week
Workers can be remote/hybrid but must be local and able to come into the office at least three days a week
Job Description:
Summary:
- This section focuses on the main purpose of the job in one to four sentences.
- Technical lead for DHF structure within sustaining engineering for disposable medical devices.
Essential Duties and Responsibilities:
- This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.
- 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 projects with minimal guidance.
- Adhere to design control procedures general safety rules company policies and procedures FDA and international regulations and guidance.
Qualifications:
- To perform this job successfully an individual must be able to perform each essential duty satisfactorily. List knowledge skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- 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.
- Experience and/or Background 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.
About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.
Employment Type
Full-time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
