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Principal Electrical Engineer

Company: ACIST Medical Systems
Location: Eden Prairie
Posted on: September 12, 2020

Job Description:

We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the ACIST team has the power to make a difference......every day!

Position Description The Principal Electrical Engineer is a key member of the Research & Technology team who provides design expertise to drive for research and development projects. These projects will consist of developing new concepts for next generation products. This position will also include development activities, which will consist of product design, development of various engineering activities like injectors, subsystems accessories, electronics and electromechanical architecture choices.

Primary Duties and Responsibilities:

Technical Supervision and Analysis

Contribution to design inputs of system, mechanics, software etc

Electronics, electrical and electromechanical specification of new electrical concepts and designs.

Close technical relationship with OEM suppliers of injector electronics, electrical and electromechanical systems or components

Supervision of OEM electronics, electrical and electromechanical development

Qualification and design transfer of the design outputs

Contributes to risk analysis at system and at electronics level

Maintains focus on Quality, Reliability, Serviceability, Manufacturability, Testability, Cost, Fulfilment of Customer needs.

Ensures products meet safety, EMC and other environmental requirements

Exhibits cooperation and sound judgment in design tradeoffs for reliable designs

Contributes to technical design reviews, may organize some when related to main duty

Contributes to design verification activities.

Contributes to supplier selection, mainly at electrical and electronics level

Contributes to advanced technology and design transfers

Technical Development and Qualification

Designs, develops, prototypes, measures, modifies and tests cost-effective electrical systems as part of electromechanical equipment concept development.

Designs, models, implements, and tests electrical circuits for DC motor control concepts.

Designs with knowledge of electronics and understands the interdependencies/design constraints with other project team members.

Develops tests for concept/design verification and validation for electromechanical products

Risk reduction and transfer of the concept outputs

Designs, builds, verifies and documents manufacturing test fixtures.

Simulates circuits and systems as appropriate to assure concept/product performance.

Diagnoses the causes of system failures and specify solutions.

Develops intellectual property to maintain competitive advantage.

Documentation and communication

Rigorous documentation, including design specifications, verification test plans, change orders associated with medical devices.

Routine communication with peers and supervisors including documentation of work, progress and decisions

Interfaces with other teams to ensure smooth sharing of information.

Directs outside contract personnel as needed for completion of specific tasks.

Quality, Compliance, and Regulated Practices

Supports Regulatory group for requirements including Product Safety, electromagnetic interference/electromagnetic compatibility (EMI/EMC), REACH/RoHS and other environmental standards.

Perform work in adherence to the Quality Management System (QMS), including development and maintenance of documentation.

Ensures products and their design meets requirements regulated by FDA, EU, MDR, ISO13485 and other governing bodies or standards.

Participates in selection of vendors and fabrication sources to assure quality and compliance to released specifications.

Occasional contribution to quality issue investigations, root cause analysis, CAPA’s

Occasional contribution to design improvements or sustaining activities

Qualifications (Knowledge, Skills & Abilities): Minimum:

Bachelor of Science in Electrical or Electronics Engineering

10+ years of electronics and electrical/electronic engineering experience

Ability to specify and evaluate components based on performance, availability, reliability and lifetime

Proved experience in complex hardware design and development

Experience in cross-functional teamwork, with mechanics, software, project management, operations...

Experience with analogue and digital electronics, power management, motor drive, communication bus

Experienced in schematic capture and printed circuit board layout CAD (ideally Altium Designer)

Experience with an analogue electronic simulation tool (ideally one based on SPICE)

Experience with engineering languages or tools like Labview, Scilab, Matlab, Simulink, Python, Minitab…

Familiarity with development and debug tools and instruments; demonstrated ability to use a soldering iron, a multimeter, an oscilloscope, a spectrum analyzer, a logic analyzer…

Experience in FPGA programming and debugging

Experience in qualification of either functions or complete designs

Understanding of EMC constraints and best related practices

Understanding of electrical safety requirements and best-related practices.

Understanding of mechanics or mechatronics

Strong interpersonal and communication skills

Strong problem-solving skills and methodology

Excellent technical writing skills

MS Office suite

Good command of technical English

Preferred:

Master of Science in Electrical or Electronics Engineering

3+ year experience in medical device design

Experience in hardware development through full product life-cycle, incl. transfer to manufacturing

Knowledge of embedded systems, microprocessors and embedded software development

Experience with a mechanical design CAD software like Solidworks

Familiarity with medical regulations and standards 21.CFR, MDR, ISO13485, IEC60601-1, IEC60601-1-2

Other:

Understanding of regulated activity constraints and limits

Understanding of documentation constraints and good documentation practices

Understanding of medical development process constraints and good design practices

Keywords: ACIST Medical Systems, Eden Prairie , Principal Electrical Engineer, Other , Eden Prairie, Minnesota

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