Principal Electrical Engineer
Why Join ACIST?
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!
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):
- 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
- 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
- Project management skills
- 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
- 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
- Understanding of business constraints