Skip to main content

This job has expired

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.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert