Medical Engineering Consultants (MEC) · 4 hours ago
Manufacturing Engineer
Maple Grove, MN
Contract
Onsite
Mid Level
3+ years expMedical Engineering Consultants (MEC) supports medical device and pharmaceutical companies by providing resources and expertise. The Manufacturing Engineer will focus on increasing the capacity of a catheter production line, driving innovative technology solutions from concept to commercialization, and collaborating with cross-functional teams.
ConsultingMedical DevicePharmaceuticalTraining
No H1B
Responsibilities
Owning equipment, processes, inspections, development builds and driving improvements in the associated technology and methodology
Positioning future projects for success to continue driving department and company goals
Own processes and key deliverables through validations of equipment, process and test methods for commercial launch
Work cross functionally and collaborate heavily with R&D, Equipment Engineering, Manufacturing Engineering and Design Assurance to develop product concepts, equipment, inspections, influence design specifications and provide Design for Manufacturability (DFM) input to the engineering print package
Developing new assembly and inspection capabilities for complex equipment
Train, mentor and/or provide work direction to engineers and technicians and may train manufacturing personnel when required as part of a validation
Communicating technical data and recommendations in a clear and concise manner
Solving complex technical problems in a hands-on manner and working in a fast-paced dynamic environment
Develop, write, review, process validation strategy and related deliverables to meet quality system requirements. e.g. Experiment tech reports GR&R, TMV, IQ, FMEAs etc
May serve as a core team member, workstream lead or extended team member on new product development projects
Build Quality into all aspects of their work by maintaining compliance to all quality requirements
Qualification
Required
Bachelors degree in engineering or relevant technical field
Minimum of 3 years of professional experience relevant to this role
Prior experience in medical device or other regulated industry
Demonstrated cross functional collaboration and influence in a technical environment
Experience with Automated Inspection and/or Assembly Equipment
Demonstrated understanding of problem solving and root cause investigations
Expertise in Operations
Experience with Process Verification and Validation such as TMVs and OQ/PQs
Demonstrated understanding and usage of statistics to drive improvements
Strong written and verbal communication decision-making and critical thinking skills
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