What are the responsibilities and job description for the Engineer I position at Gentherm?
At Gentherm, we say, "It's about the person." We're with you on a cold winter day when you turn on your heated seat and steering wheel or helping manage patient body temperature in the operating room, recovering room or intensive care units. We take a human approach with everything we do.
As the global market leader of innovative thermal management and pneumatic comfort technologies for the automotive industry we embrace the opportunity to create and deliver extraordinary solutions that make meaningful differences in everyday life. We do this by improving health, wellness, comfort and energy efficiency.
We embrace an entrepreneurial spirit and combine that with our global leadership to deliver results. Working at Gentherm provides you the opportunity to not only shape the future of the automotive and medical industries, but also influence your career throughout the company. You will be engaged, challenged and inspired by our team to deliver leading thermal technologies that positively impact lives around the world.
The Engineer I is a highly motivated problem solver with an understanding of the product offerings and engineering processes. This team member manages small scale legacy projects and provides engineering product/process support to meet needs of the business. Typically, work is performed with moderate oversight/guidance.
- Provide engineering solutions to opportunities presented by the business.
- Manage and drive small scale engineering projects from initiation through implementation under close supervision and support.
- Create, support, and review deliverables for new product development projects (i.e. design input requirements, design output requirements, etc.).
- Provide engineering support cross functionally throughout the products life cycle.
- Demonstrate a basic understanding of the QMS and its governing procedures.
- Demonstrate a basic understanding of the applicable standards (i.e. ISO 13485, IEC-80601-2-35, 21CFR Part 820, etc.).
- Demonstrate a basic technical understanding of all product offerings.
- Responsible for creating/maintaining product's design history files/device master records.
- Identify opportunities for product and process improvement.
- Supports Quality Department with engineering evaluation/analysis for nonconformances (NC's) complaints, deviations and corrective and preventive actions (CAPA's).
- Bachelor of Science (BS) in Engineering or Physical Science.
- 2 years of applicable experience
- Strong communication skills. Must be able to effectively communicate and present project information to general audiences, as well as across departments and corporate business units.
- Strong documentation skills. Must be proficient in GDP practices.
- Understanding the importance of compliance with respect to device safety and efficacy, ramification of non-compliance, general safety rules, manufacturing procedures, company policies and applicable procedures, ISO, QSR and FDA regulations.
- Proficient in Office Suite programs, 2-D/3-D modeling software.
- Change control experience.
- Design and development experience.
- Experience working within a QMS.
- Basic understanding of applicable regulatory standards (i.e. ISO 14971, IEC 60601, 21CFR Part 820, IEC 80601-2-35).
- Experience maintaining/revising DHR/DMR documents.
- Understanding of GD&T and reading engineering drawings/prints
- Process improvement experience.
- Experience working in medical device environment.
- Project management/leadership experience.
- Understanding of heat transfer/thermal management systems.
- Proficient in Visual CRM software and Adobe Suite programs.
- Experience authoring and executing verification/validation testing.
- Deliver Results
- Understand the mission and output of your team; set SMART objectives and deliver
- Drive Change
- Focus on agility and commitment to continuous improvement; Understand and act on internal and external drivers of change
- Build Capability
- Foster a culture of learning and development; Support individual growth through continuous feedback to achieve personal and professional goals
- Cultivate Innovation
- Openly embrace, create, implement and support new and innovative ideas, processes and technology that deliver business results
Gentherm is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, genetic information, sexual orientation, gender identity, disability or protected veteran status.
Nearest Major Market: Cincinnati
Job Segment:
Thermal Engineering, Medical Device Engineer, Business Process, Compliance, Testing, Engineering, Management, Technology, Legal
