Leader in medical device manufacturing is looking for Principal Engineer in Round Lake, IL for a contract role expected to last 12 months, possible extension, possible temp to perm.
This position will support the operational
activities for development of studies, assessments, and document materials for submission to TUV, to meet the regulatory timing for Europe Medical Devices Regulation (MDR).
Collaborate with Design Owning organization (DOO) and the other support functions, taking the role of coordination and planning of activities related to the above-mentioned initiatives. He/she will work with the Resource Manager, and act as a conduit for the relationship between the Renal sustaining organization and external consulting resources.
Bachelor's degree in a scientific discipline (such as Biomedical Engineering, Chemical Engineering, Material Engineering, Chemistry, Pharmaceutical Sciences or related field) with 5-8 years or MS with least 2-5 years' experience in relevant discipline.
Great Contractor Benefits! Apply Now!
location: Round Lake, Illinois
job type: Contract
salary: $48 - 60 per hour
work hours: 8am to 5pm
Coordination and planning support for Gap Assessment, Remediation and Submission dossier, initiatives, managed by DOO R&D and other support functions, including external Contractors Engineers Responsible for tracking external expenditure budget mgmt Effectively liaise with different stakeholders from varying geographies/cultures/functions, such as Design Owning Organization,Regulatory Affairs, Quality and Subject Matter Experts (e.g. E&L, Preclinical, Materials Science, Sterility) to communicate program needs and requirements. Coordinate plans with Resource Mgr / LSD Duties
- Understands risk-based approaches used in medical devices.
- Feels comfortable dealing with ambiguity and maintains effectiveness when working with limited information or experiencing changes.
- Routinely provide advice and assistance to team members regarding problems and project work.
- Highlights roadblocks affecting execution, removes them or proposes a way to overcome them, supporting the decision process.
- Solves operational and technical level problems that are straightforward and well-defined in scope.
- Identifies opportunities to simplify the complex with respect to people, process and tools.
- Able to communicate clearly with manager, peers, cross-functional teammates, and non-technical audiences.
- Demonstrates understanding of and adherence to governmental and international industry requirements, procedures, regulations and standards related with EU-MDR and applicable E&L standards and guidelines.
- Maintains and generates documentation in compliance with GLPs.
Background and/or Experience
- Understanding of materials safety and intended clinical use is a plus. Knowledge of medical devices manufacturing processes is preferred.
- Good knowledge of word processing, spreadsheets, data collection and pivot tables.
- Working knowledge of industry regulations, GMP, ISO, MDR, ICH, USP, food contact legislations or other similar regulated environments.
- strong organizational and time-management skills.
- Must have good communication skills, including English proficiency.
- Good team player to interface with team members in other areas.
- Knowledge should include experience with device Design History File structure, Risk Management documentation and Product Requirements management Capable of communicating and driving cross-functional teams globally.
- Ability to communicate up courses of action with minimal assistance using both written and verbal methods.
Bachelor's degree in a scientific discipline (such as Biomedical Engineering
, Chemical Engineering
, Material Engineering
, Chemistry, Pharmaceutical Sciences or related field
) with 5-8 years or MS with least 2-5 years' experience in relevant discipline.
- Experience level: Experienced
- Education: Bachelors
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.