Medical Engineering Consultants (MEC) · 18 hours ago
R&D Engineer
Arden Hills, MN
Contract
Hybrid
Mid Level
4+ years expMedical Engineering Consultants (MEC) supports medical device and pharmaceutical companies by providing resources, knowledge, and expertise. They are seeking an R&D Engineer to assist in integrating design history files for a nerve stimulation product, ensuring compliance with quality systems and identifying gaps in design inputs and outputs.
ConsultingMedical DevicePharmaceuticalTraining
No H1B
Responsibilities
Identifying gaps in the acquired company's DHF to our client's Work Instructions and SOPs and contributing to strategy to close these gaps specifically on a trial nerve stimulator device for overactive bladder
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
Successfully completing engineering work in one or more of the following: Device Requirements Design, FMEA, Design Verification, test method validation, DV protocol testing and report Essential Design Output identification and requirements tracing
Completing clear and concise engineering documentation including protocols, reports and rationales
Demonstrating Technology Development and Product Development system knowledge through delivery of high-quality high impact deliverables
Qualification
Required
BS or above in Mechanical Engineering, Biomedical Engineering Electromechanical Engineering or related field
4 yrs of medical device engineering experience
IF MS degree, 2 years of experience
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
10% travel to California site twice during assignment
Preferred
Familiarity with IEC 14708 and 45502 Active Implantable standards
Familiarity with IEC 60601 Medical Electrical Equipment standards including laser-specific sections
DMAIC problem-solving skills
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