Medical Engineering Consultants (MEC) ยท 23 hours ago
R&D Engineer
Arden Hills, MN
Contract
Onsite
Mid Level
4+ years expMedical Engineering Consultants (MEC) supports medical device and pharmaceutical companies by providing resources and expertise. They are seeking an R&D Engineer to validate test methods and provide technical support in the Urology Research and Development organization, focusing on compliance and integration of medical device technologies.
ConsultingMedical DevicePharmaceuticalTraining
No H1B
Responsibilities
Identifying gaps in the acquired company's test method validations to compliance with our client's Work Instructions
Providing input to project goals and progress and recommending appropriate revisions
Communicating progress, risks and trade-offs of technical deliverables to project leadership and recommending revisions as needed
Completing complex or novel assignments requiring the development of new or improved techniques and procedures
Work is expected to result in efficient and effective integration of medical device technologies to our client's portfolio
Successfully completing engineering work in one or more of the following: technology development or remediation, product design refinement, test of materials, preparation of specifications, process study and report preparation
Assessing the feasibility and soundness of alternative engineering processes, products or equipment
Completing clear and concise engineering documentation
Demonstrating Technology Development and Product Development system knowledge through delivery of high quality high impact deliverables
Qualification
Required
Windchill and Test Method Validation experience required
BS or above in Mechanical Engineering, Biomedical Engineering, Electromechanical Engineering or related field
4 yrs of engineering or related experience with bachelors degree or 2 yrs with Masters
Strong mechanical and/or systems engineering and problem-solving skills and attention to detail
Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources
Strong written and verbal communication, judgment, decision-making, collaboration and critical thinking skills
Personal drive, individual accountability, a strong bias for action
Preferred
Familiarity with IEC 14708 and 45502 Active Implantable standards
Familiarity with IEC 60601 Medical Electrical Equipment standards including laser-specific sections
Experience with statistical techniques, Gauge R&R, Process Capabilities Studies and Minitab
Experience in single-use device or active implantable test methods and test method validation
Ability to build strong relationships across the organization and with external stakeholders
Company
Medical Engineering Consultants (MEC)
MEC is a comprehensive solution provider with a full suite of services from consulting and contracting to training and cost savings initiatives.
Founded in 2011Fort Lauderdale, Florida, USA
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Christopher Gustine
Managing Partner
David Campo
Managing Partner
Company data provided by crunchbase