Sr Design Engineer SolidWorks Design Experience for Catheters

Company Name:
Helix Medical
MedVenture Technology, a Helix Medical company is a global leader in medical device development and contract manufacturing. We offer the following services for medical device, pharmaceutical and IVD clients worldwide: product design and development, silicone and thermoplastic molding and extrusion, complex catheter systems, assembly, packaging, and engineering services.
For nearly 30 years, medical device and healthcare companies around the world have looked to Helix Medical to make a difference as the custom manufacturer medical industry leaders can trust. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms. Helix Medical Companies maintain design and manufacturing centers in California, Indiana, Massachusetts, Minnesota, Costa Rica, Germany, Ireland, and China.
MedVenture manufactures minimally invasive, handheld and catheter-based devices out of our 93,000 square foot state-of-the-art facility, strategically and centrally located in Jeffersonville, Indiana. MedVentures culture is positive and team oriented. In our environment we like to have fun while helping others with our cutting edge medical devices. Our company is very driven to lead in the medical device industry to improve the quality of life of the patients we serve.
We are currently hiring for a Sr Design Engineer who is:
Driven, self-starter with a focus on ensuring quality development for new catheter products.
Energetic and has a Make it Happen attitude.
Organized and creative with the ability to work with customers and design targeted products to meet their needs.
Self-motivated and thrives in a fast paced, cutting-edge environment.
Basic Responsibilities
Apply engineering knowledge to the design and development of new products and product changes and enhancements to existing products.
Perform functions to establish feasibility of concepts and determine specific design inputs and requirements for new products.
Perform risk analysis and reliability activities for new and existing products along with responsible for Technical Device Reviews
Design new and existing products including, but not limited to, solid modeling (SolidWorks preferred), specifications and tolerances.
Support the development of product test methods and incoming inspection requirements
Responsible for design and development of product packaging and labeling
Perform design verification and validation to include protocol development, builds, testing, and reports while communicating design related issues with internal and external team members
Maintain current knowledge of competitive technologies in the medical device industry.
Support the development of manufacturing processes and procedures
Support the project manager in project planning and execution of design related activities
Write invention disclosure to support patent applications.
Provide mechanical engineering support in the resolution of product complaints and/or safety issues.
Support design and process improvements post transfer to sustaining manufacturing
Provide proper documentation for design tasks to support FDA Quality System requirements, other regulatory bodies and customer requirements. (e.g. lab notebooks or technical memos)
Develop and manage the Design FMEA and design traceability matrix (DTM)
Formal and informal build protocols and reports
Assign work to technicians and temporary employees as needed while mentoring lower level design engineers
Provide leadership and direction on project teams as it relates to the design engineering functions.
Required Qualifications
Bachelor of Science degree in Mechanical Engineering (or related disciple) and experience, in the medical device field.
5 - 10 years of mechanical design/product design experience.
Extensive experience with SolidWorks CAD (design, assembly & drawings)
Some experience with Catheters and Electrophysiology (EP) Systems
Ability to identify and create unique and innovative designs.
Ability to formalize concepts for production fabrication of parts and assemblies.
Ability to create detail drawings for production fabrication of parts and assemblies.
Working knowledge of Geometric Dimensioning & Tolerance (GD&T)
Knowledge of materials and the characteristics of parts when fabricated from different materials (e.g. polymers and metals).
Knowledge of tooling and process to produce component parts.
Understanding of various manufacturing and production monitoring techniques.
Ability to use analytical techniques for design verification, problem and root cause analysis.
Working knowledge of both FDA and CE design controls
Leadership ability and organizational skills
Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work
Proficiency in the use of PC and programs, particularly Excel, Project, PowerPoint and Word to create documents.
Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) both to senior management, customers and associates
Execute tasks in a timely manner without direct supervision.
Able to prioritize tasks.
Its an exciting time to work at MedVenture Technology. We know our ability to succeed depends upon the people we employ. Leading-edge technology, the highest standards, and outstanding people make MedVenture Technology the employer of choice in this industry. We offer a competitive salary plus a full range of benefits including medical, dental and vision insurance, as well as 401K Match. Learn more at http://medventure.com/careers/ and http://www.helixmedical.com/careers
To Apply:
Candidates meeting these qualifications should complete the online application: https://freudenberg-jobs.dvinci.de/cgi-bin/appl/selfservice.pl?action=startapp;job_pub_nr=DB21ABC4-E5AA-4408-92D3-D1B04A454317;p=homepage_com;job_pub_type=extern
MedVenture a Helix Medical Company is an Equal Employment Opportunity Employer.

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