R&D Engineer

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.

• Position will be working on a new high-profile project.
  
  

About The Role

This R&D Sr. Mechanical Engineer will be part of the Peripheral Interventions IOE mechanical team and will focus primarily on new product development that will include a variety of single-use devices used for cryoablation of tissue. Day-to-day work will include a variety of activities such as mechanical design, SolidWorks, hands-on lab work, data analysis, documentation, task planning and coordination and collaboration with others.

• A strong mechanical aptitude is a must.
  
  

Roles And Responsibilities

• Fully participates in and successfully contributes to project teams, typically including the following activities:

• product design and development test of materials, preparation of specifications, process capability studies, report preparation and planning/coordination of work.
• Works independently to plan and schedule own activities necessary to meet timelines.
• Trains and/or provides work direction to technicians and junior engineers as necessary.
• Designs and coordinates standard engineering tests and experiments.
• Designs, procures and fabricates tooling and fixtures.
• Performs troubleshooting on new products/process problems as related to design, material or process.
• Summarizes, analyzes and draws conclusions from test results.
• Prepares standard reports/documentation to communicate results to technical community.
• Invents/creates concepts and designs for new products, processes and submits idea disclosures.
• Works cooperatively with process development, quality, manufacturing, regulatory, clinical and marketing to ensure project success.
• Consults and solicits feedback from internal stakeholders to identify customer needs and translate these requirements into the mechanical designs.
• In addition provides support regarding product development to internal departments as it relates to mechanical design.
• Demonstrates PDP/TDP system knowledge through delivery of high-quality deliverables.
  
  

Quality Systems Duties And Responsibilities

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Qualifications

• Degree in Mechanical Engineering. FIRM.
• 5+ years of engineering work experience with a minimum of 3 years of medical device development experience.
• Relevant advanced education considered as substitute for work experience.
• Thermodynamics, fluid dynamics, and/or catheter design experience/education is desired.
• Cryoablation product development experience is a plus.
• Highly self-motivated and directed.
• Proven analytical and problem-solving abilities.
• Proficient in SolidWorks.
• Significant experience with hands-on building and testing of single-use device prototypes.
• Strong mechanical aptitude and broad knowledge of materials.
  
  

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
  
  

Check us out at www.medicalengineeringconsultants.com

AAP/EEO DFWP

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.