Biomedical Engineer Technical Lead
- Employer
- Monteris Medical
- Location
- Minnetonka, Minnesota
- Start date
- Oct 7, 2024
- Closing date
- Oct 14, 2024
View more categoriesView less categories
- Category
- Engineering
- Job Type
- Employee
- Employment Status
- Full Time
Biomedical Engineer Technical Lead
Biomedical Engineer Technical Lead - Monteris Medical Corp, Minnetonka, Minnesota. Successfully work in and across a hybrid work environment, remote and in office. Req. Bach. Deg in Biomedical Engineering or rel eng discipline & at least 2 yrs of pre or post bach exp.as an engr, intern/fellow, or analyst in medical device industry. Also req. at least 1 yr exp. w/ the following: Exp. w/ Class 2 Medical Devices; Understanding & assessing applicable regulations & standards w/in the Code of Federal Regulations (CFR), Health Canada SOR 98-282, ISO Standards, ASTM Standard Test Methods, & ASME Standards for Engineering Drawings; Exp. w/ 21 CFR Part 820, 21 CFR Part 803, ISO 13845, & ISO 14971; Working on complaint record intake, escalation, evaluation, investigation, regulatory reporting, review, & closure of complaints in a timely, thorough, &compliant manner; Working on medical device decontamination for investigation; Engaging in Medical Device Reporting (MDR) to the FDA;Working w/ MS Suite (such as MS Word, Excel, & PowerPoint); Engaging in Quality System data management, analytics, review & professional presenting for trends; Modifying, importing & exporting data w/electronic Quality Management Systems & Learning.Management Systems, including at a Systems Administration level; Modifying, importing & exporting data electronic Requirements Management Tools; Configuring, transferring, importing/exporting & creating data visualizations between multiple electronic systems; Engaging in tech. writing; Writing & executing tech. protocols & reports for data analytics & reports validations; & working w/cross-functional teams & across all levels of the org., including working w/ tech. field clinical specialists, engineering, operators, executives & external parties such as vendors, gov. agencies & physicians; Creating content for marketing, tech. presentations for both internal & customer-facing documents in compliance w/ all applicable reg.; Presenting information professionally to internal & external auditors; Working in controlled environment, Magnetic Resonance Imaging (MDI) environment, & Operating Room (OR) environments; Must be
credentialed or possess the ability to be credentialed for hospital access to MRI & OR. For confidential consideration, please submit resume via email: careers@monteris.com. No agencies or phone calls please.
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