| Job Description | SUMMARY
As an integral part of a cross-disciplinary design team (Sourcing, QA, Manufacturing, etc.) this resource will design, develop, test and participate in the launch of medical device products. This candidate must have experience implementing projects plans from design concept through to product implementation. This engineer will contribute to the design team based on expertise and experience in various areas of electrical engineering design. This resource will lead designers, technicians and engineering peers in the design and building of medical devices and associated drawing packages. This resource will also create test procedures and product performance requirements to ensure quality and compliance standards are met. He/She will lead design qualification test activities, and oversee prototypes and final product development. Testing activities will include software testing, system functional tests, thermal tests, electrical performance, electrical safety, EMC and ESD. As such, He/She will perform a full range of professional engineering duties, project assignments with minimal supervision, and will serve as R&D lead on at times multiple projects. He/She must be able to solve complex problems by applying knowledge of engineering or scientific principles to accomplish technical assignments within core discipline. He/She must effectively engage projects that could span several engineering areas of concentration, (e.g. Embedded Systems, Electrical/Electronic, Mechanical, and Optical).
Products are developed to meet FDA requirements. Candidate must demonstrate an understanding of typical Product Lifecycle Management suitable for the medical device design industry.
ESSENTIAL JOB FUNCTIONS
1. Serves as technical leader and electrical engineering subject matter expert on R&D projects
2. Applies standard engineering design principles and methodology to R&D option evaluations and experiments to determine potential design feasibility or application
3. Coordinates activities between cross-functional team members and R&D design team to create, review, and release product requirements and design specifications
4. Establishes initial R&D project schedule estimates and maintains project schedules, including defining designer support tasks and completion milestones
5. Designs, implements, reviews and tests electrical designs and embedded systems for medical equipment that incorporate complex new technology
6. Writes and reviews design specifications for new product features
7. Leads or participates in brainstorm sessions, ideation sessions and design reviews
8. Manages internal and external design resources, when appropriate
9. Conducts and participates in peer reviews to ensure product quality
10. Designs and develops prototypes to evaluate new technology and assess feasibility
11. Coordinates prototype design, test, and build activities with designers and other R&D team members
12. Conducts and evaluates product lifecycle testing
13. Follows trends in the market and evaluate applicability to our medical products
14. Reviews product documentation for accuracy including documentation intended for customer use
15. Develops manufacturing functional test systems for use during product assembly
16. Designs and creates electrical system schematics
17. Designs and creates design qualification test systems
Requirements
Education & Experience:
Bachelor’s degree in Electrical Engineering and a minimum of 7 years related experience or equivalent combination of education and demonstrable experience in the following areas.
Leadership Skills:
1. Ability to assess the feasibility of design modifications to existing designs
2. Hands on experience with developing new products from concept to market release through a phase gates product development process utilizing internal and external resources
3. Experience leading meetings consisting of cross-disciplinary design teams and other functions.
4. Ability to lead development activities performed by external consultants
5. Ability to serve as R&D lead managing a variety of technical deliverables on multiple projects, while delivering several key technical designs
Technical Skills:
1. Systems design engineering experience with a focus on electrical hardware design including power & delivery system design, controls system, enclosure design, system interconnection/harness design, user interface design and digital/analog hardware design
2. Experience with development of control algorithms
3. Understands and applies user interface design practices
4. Strong aptitude in the development of software and hardware requirements
5. Ability to utilize an electrical CAD package such as ACAD or modeling package such as Pro-E
6. Familiar with PCB CAD package such as OrCad, or similar commercially available software
7. Familiar with PCB assembly, test and manufacturing requirements
8. Regulatory compliance experience with designing equipment to comply with applicable industry standards such as UL, IEC, TUV, CE, CSA, ESD, EMC, etc…
9. Ability to analyze electrical circuit designs and familiar with A/D conversion and signal conditioning.
10. Familiarity with common support IC's application
11. Ability to analyze IC chip and electrical component usage (analog and digital) to check application, operating margins or perform component substitution
12. Familiarity with data acquisition systems, instrumentation, various meters, scopes, analyzers and equipment calibration
13. Experience in development of qualification test plans and execution, including software V&V
Organization, Productivity and Communication Skills:
1. Strong Customer focus
2. Experience with design controls and documentation requirements (e.g. generation and maintenance of design history files)
3. Strong Computer skills (MS Word, Excel, PowerPoint, Outlook, Internet)
4. Excellent interpersonal, written and verbal communication skills
5. Well developed, detail oriented organizational skill
6. Ability to work with management to set and achieve goals based on priorities of development projects and support of internal and external customers
7. Excellent presentation skills
Physical Requirements:
1. Some lifting (30+lbs) occasionally required during product assembly and test
2. Ability to travel domestic and international working with our compliance agency and suppliers (10%)
Additional Experience a Plus:
1. Medical Device Directive (MDD), ISO 13485, FDA design controls or similar regulatory environment
2. Compliance to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 62304, UL60601-1
3. Programming experience (e.g. embedded s/w, Visual Basic, C, C++, etc…)
4. Wired and wireless communication technology
5. Video signal and video integration
STERIS is a $1B+, publicly traded (NYSE) organization of over 5000 employees and is dedicated to providing innovative infection prevention, decontamination, and health science technologies, products and services. STERIS Corporation is an equal opportunity/affirmative action employer.
STERIS Corporation complies with all obligations with respect to online application systems under guidelines provided by the US Department of Labor's Office of Federal Contract Compliance Programs. If you are a disabled person who requires reasonable accommodation to complete an online application, please contact the STERIS Human Resources Department by phone at 440-392-7047 or 800-548-4873, extension 27047 for assistance. |
| | Company | | STERIS Corporation | Job Code | | State or Province | | Ohio | | |
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