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Associate Medical Device Labeling Jobs in Colorado

Rep-Lite

SPD Field Account Specialist - 61

Denver, CO · On-site

$65K - $70K/yr

Associate Medical Device Representative * Scrub Tech or candidates with orthopedic or technical device exposure Education & Certifications * Associate's degree preferred, not required * CRCST / CBSPD ...

Abbott

Field Service Technician (Medical)Remote

Denver, CO · On-site

$22 - $26/hr

... device systems and system components. Up to 80 - 90% domestic travel is required for this role ... Associates or technical degree required (or relevant experience) Bachelor's degree in Biomedical ...

smartdept. inc.

Senior Graphic Designer

Denver, CO · On-site

$66K - $91K/yr

smartdept. is searching for a Senior Designer for a medical device client located in the Denver, CO ... Associate's degree in design and/or certificate in graphic design required * 10+ years of ...

IQVIA

Medtech Clinical Nurse Educator

Denver, CO

$40.50 - $55/hr

... the medical device * Provide updates, reports, and valuable feedback to client during and after in-service assignments Job Requirements: * RN Degree - Associates required, Bachelor's preferred

Aerotek

Entry-Level Packager/ Machine Operator

Monument, CO · On-site

$17 - $19.55/hr

Packager / Machine Operator - Medical Device Location: Monument, CO About the Role We are hiring ... Operate packaging and labeling equipment * Perform routine quality inspections to ensure products ...

Three Point Solutions

Test Technician

Lafayette, CO · On-site

$30 - $35/hr

Medical Device Manufacturing Industry Location: Lafayette, CO 80026 Duration: 12 Months (Possible ... Associate Degree, Military Technical Training, or equivalent experience preferred • Minimum 4 ...

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All JobsAssociate Medical Device Labeling JobsAssociate Medical Device Labeling Jobs in Colorado

Associate Medical Device Labeling information

What are some common challenges faced by Associate Medical Device Labeling professionals, and how can they be addressed?

Associate Medical Device Labeling professionals often encounter challenges such as keeping up with evolving regulatory requirements across different countries, ensuring accuracy and clarity in complex technical information, and coordinating input from multiple departments like regulatory affairs, engineering, and marketing. Addressing these challenges involves staying updated on global labeling standards, developing strong attention to detail, and building effective communication and collaboration skills. Leveraging project management tools and regularly participating in training can also help manage these complexities and ensure timely, compliant labeling deliverables.

What are Associate Medical Device Labeling professionals?

Associate Medical Device Labeling professionals are responsible for creating, reviewing, and maintaining the labeling and packaging materials for medical devices. Their work ensures that all product information, instructions, and regulatory warnings are accurate, clear, and compliant with industry regulations. They collaborate closely with regulatory affairs, quality assurance, and product development teams to make sure that labels meet local and international standards. This role is critical in helping ensure patient safety and regulatory approval of medical devices.

What are the key skills and qualifications needed to thrive as an Associate Medical Device Labeling Specialist, and why are they important?

To thrive as an Associate Medical Device Labeling Specialist, you need a strong understanding of regulatory requirements, attention to detail, and experience in technical writing, often supported by a degree in life sciences or a related field. Familiarity with labeling software, document management systems, and knowledge of FDA or EU MDR regulations are typically required. Excellent communication, collaboration, and organizational skills set top performers apart in this position. These skills are crucial to ensure label accuracy, regulatory compliance, and patient safety in a highly regulated industry.
What cities in Colorado are hiring for Associate Medical Device Labeling jobs? Cities in Colorado with the most Associate Medical Device Labeling job openings:
Associate Medical Device Labeling jobs near you

Sr Packaging Engineer I

Highridge Medical

Westminster, CO • On-site

$83K - $100K/yr

Full-time

Posted 4 days ago

Job description

Sr Packaging Engineer I

Principal Duties and Responsibilities:

Supports the design and development of new packaging systems and/or improvements from conception to launch following Design Control procedures. Packaging designs include cases, trays, containers, as well as sterile packaging including sterile barrier systems and transport packaging.

Oversees design work, validation, and testing of sterile and non-sterile packaging systems, ensuring integrity, safety, and compliance with regulations.

Develops project plans and manages critical project timelines.

Collects cross-functional and user feedback to define user needs, specifications, and performance criteria related to packaging systems including protection, sterility, and usability.

Manipulates CAD models and engineering drawings primarily within SolidWorks.

Authors and maintains design control documentation within a DHF.

Supports test strategy development and validation requirements for sterile and non-sterile products and contributes to test protocol/report creation.

Defines and coordinates packaging verification and validation activities, including distribution testing, seal integrity, shelf-life/aging studies, and any other relevant testing and/or evaluations.

Reviews design and materials for manufacturability, inspectability, and cost-effectiveness.

Participates in root cause investigations and corrective actions related to packaging systems including sterile barrier failures and distribution related issues.

Supports creation and maintenance of Bills of Materials (BOMs).

Owns and authors packaging procedures, work instructions, and processes as the Packaging subject matter expert.

May participate in label creation and definition of other items comprising the final finished packaged good.

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

Expected Areas of Competence (i.e., knowledge, skills, and abilities)

Full working knowledge of and moderate level of experience with packaging development, including both sterile and non-sterile systems, and familiarity with design control processes.

Working knowledge of sterile barrier systems (SBS), including material selection, sterilization compatibility, and package integrity methods.

Demonstrated ability to methodically investigate technical issues, identify appropriate solutions, and apply current technologies to resolve problems.

Ability to develop and maintain project schedules and track cross-functional team progress to meet deadlines.

Ability to address nonconforming product, and provide sound technical recommendations.

Professional, concise, and tactful communications with internal teams and external stakeholders, including surgeons and suppliers.

Effectively communicates with internal personnel, external customers, and vendors to accomplish project objectives.

Effective written and verbal communication skills, including the ability to create and deliver technical presentations.

Familiarity with and ability to support Quality Assurance and Regulatory requirements applicable to the medical device industry.

Ability to manage multiple projects at one time throughout all stages of the development process.

Proficient in CAD design and engineering drawings, preferably using SolidWorks.

Proficient with Microsoft Office Suite and MS Project.

Education/Experience Requirements

Minimum B.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines: Mechanical Engineering, Mechanical Engineering Technology, Industrial Engineering or Packaging Engineering.

3-7 years of experience in the Medical device industry, particularly in orthopaedic devices with sterile packaging systems.

Travel Requirements

Up to 10%

Salary Range $83,000.00- 100,000.00

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