Sr Design Engineer

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.
MedVenture Technology is a local, innovative, high growth company with a collaborative, high performance work environment. We develop and manufacture minimally invasive, single use medical devices in the endoscopy, cardiovascular, neurovascular, and urology markets. The products we develop and manufacture are typically market disruptive and displace higher cost procedures. We currently have 250+ employees and are looking for a Sr. Design Engineer to help us grow the business. Our engineers work on multiple products and product platforms and ensure that or products meet or exceed quality guidelines and expectations.
We are currently hiring for a Sr. Design Engineer who has:
Minimum 10 years of medical device experience, preferably in interventional devices and catheters
Broad experience in various product and process technologies
Project leadership experience with some project management skills
Ability to fill a variety of different roles within a project (ideation, design, process, project planning/management)
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.
Develop project schedule and work with team to adhere to schedule
Work with physicians to gain clinical input for designs
Author presentations to present project updates and to present to external customers
Perform risk analysis and reliability activities for new and existing products.
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, incoming inspection requirements and product packaging and labeling.
Perform design verification and validation to include protocol development, builds, testing, and reports.
Maintain current knowledge of competitive technologies in the medical device industry.
Support the development of manufacturing processes and procedures
Write invention disclosure to support patent applications.
Serve as project leader as assigned and develop project schedule(s)
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 Hazard Analysis, design traceability matrix (DTM) along with formal and informal protocols and reports and document Inventions.
Assign work to technicians, peers and temporary employees as needed along with oversee and assist in the selection of outside vendors and consultants as required.
Provide leadership and direction on project teams as it relates to the design engineering deliverables.
Manage schedule and while providing technical leadership.
Required Qualifications
Four year engineering degree, BSME or BSBME preferred. Relevant experience in lieu of a degree shall be considered on a case-by-case basis.
11-15 years Experienced in all job requirements within the medical device industry
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
Ability to build and manage project schedules
Run project meetings
Experience with interacting and working with physicians and outside customers
Physical Demands
Working in a controlled environment fully gowned.
Periodic travel
Ability to work extended hours as necessary
Work in animal labs or with animal tissue
Physical Requirements; Light work: Exerting up to 20 pounds of force occasionally to move objects
Visual Requirements; Close visual acuity to perform activity exp. Small parts, operation of machines, viewing a computer
Visual acuity to perform activity exp: operating machines within arms reach
Visual acuity to operate motor vehicles or heavy equipment
Visual acuity to determine accuracy and thoroughness of work assigned
The conditions you are subject to in this position
Subject to noise that may cause you to shout in order to be heard
Subject to hazards such as; moving mechanical parts, moving vehicles, electrical current, working on scaffolding and high places, exposure to high hear or exposure to chemicals.
Subject to atmospheric conditions: one or more of the following conditions that affect the respiratory system or the skin: fumes, odors, dusts, mists, gases or poor ventilation.
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=C7D4D2F8-BCE4-4C32-A14A-05378F646DF8;p=homepage_com;job_pub_type=extern
Helix Medical is an Equal Employment Opportunity Employer.

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