Manufacturing Engineer

Job Manufacturing Engineer - Located near Minneapolis, MN
**Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients' needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.

MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME's (Subject Matter Experts).

MEC's mission is to inspire positive cultural change from within, and always exceed our clients' expectations.**
ONSITE

About The Role
Our client values collaboration and synergy. We are looking for a motivated, collaborative and creative individual to join our high-performing Process Development team. This role will be focused on next generation technologies and products for a market leading device and will have strong opportunity for future growth. You will have the opportunity to drive innovative technology solutions from concept to commercialization. You will be partnering cross-functionally with a technically strong, experienced and highly engaged team.

Responsibilities Include

• Owning equipment, processes, inspections, development builds and driving improvements in the associated technology and methodology
• Positioning future projects for success to continue driving Human Visual Inspection (HVI) reduction for manufacturing
• Own processes and key deliverables through DV, PV and 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

Quality Systems Duties And Responsibilities
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Required Qualifications

• Bachelors degree in engineering or relevant technical field
• Minimum of 4 years of professional experience relevant to this role - Firm.
• 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 New Product Development and/or 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.
• Potential travel up to 10% of time. Travel will be local only - no overnight travel.

Preferred

• Experience with Nitinol manufacturing

MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.

• Sponsorship is not available for this position

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Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.