Devicix (www.devicix.com) is the engineering and product development services unit for Nortech Systems, Inc. Devicix brings value to medical device OEMs by offering innovative design solutions and comprehensive product development services for Class I, II and III devices for a range of clinical applications. We enable our partners – through our capabilities and expertise – to focus on bringing their new, exciting applications to market quickly and effectively.
Devicix is currently hiring for the following position:
Mechanical Engineer (Eden Prairie)
(All applicants must be US Citizen or US persons due to ITAR regulation)
Strong work ethic, initiative and drive coupled with a solid foundation and experience generates a great combination of attributes for the Mechanical Engineer we seek. We will rely on you for conceiving, prototyping, developing and testing novel solutions and systems in accordance with customer expectations and design standards. They take an engineering-based problem solving approach to developing designs and solutions to problems. Our ME’s lead the development of medical device design history file (DHF) documentation including ones such as requirements, risk management analyses, test protocols and reports. We will rely on you to perform the following:
Developing engineered solutions designed for manufacturing, using an analysis based approach.
Independent completion of project task work on fluid systems, materials and molding processes, electromechanical systems, enclosures and mechanical packaging, and disposable and implantable devices.
Technical expertise in mechanics, dynamics and fluids.
Leading designers and technicians in the developing of solutions.
Design history file documentation deliverables including requirements, risk management analyses, test protocols and reports.
Ability to manage time & schedule of assigned project tasks and manage multiple priorities.
Communicating project tasks status and action items.
Developing manufacturing processes and supporting prototype to verification builds.
Evaluates mechanical and electromechanical systems and products by designing and conducting research programs; applying principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials.
Creates test protocols and reports for verification testing
Researches and analyzes experimental data to understand design issues and set a direction for issue resolution
Minimum Bachelor of Science in Mechanical Engineering.
Minimum 5+ years of experience in new product development; includes experience with the product development process ranging from requirements development, prototyping, verification and product release.
Experience in medical device design and/or other regulated industries.
Must have demonstrated experience working on electromechanical systems.
Skilled in report writing, and design & documentation controls.
(Desired) Experience with IEC 60601-1.
(Desired) Experience with ISO 14971 Risk Management for Medical Devices.
(Preferred) Minimum 3+ years of experience including demonstrated experience in completing projects and/or designing solutions.
Benefits: Devicix offers its employees:
Generous salary with bonus opportunities and full benefits package including a 401(k) plan, medical, dental and vision plan and tuition reimbursement.
Devicix has a positive collaborative work culture that supports employees as they take on new challenges and grow their skills to be successful in their careers.
In addition, Devicix offers a wide range of career growth flexibility; experience working in teams with multiple engineering disciplines, a fun, fast-paced environment, and the ability to be part of designing medical products that help people’s lives!
Visit our Career page at nortechsys.com for more information on our employee benefits.
To respond to this opportunity, please go to:
Nortech Systems, Inc. is an equal opportunity employer and substance free workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Substance Free Workplace
Certain positions at Nortech require access to
information, or technology that is subject to the International Traffic in Arms
Regulations (ITAR) and other US government security regulations. These laws do
not permit access rights to non-US citizens, or to other unauthorized
individuals. Therefore, presently, all applicants must be US Citizens, or US
Permanent Residents (“green card holders”), and/or otherwise comply with ITAR
requirements for access rights, to be considered for a position.