8 days old

Senior Electrical Engineer

Merz North America, Inc
Mesa, AZ 85201
  • Job Code
    SRELE02365

This individual will be an important member of the Merz Product Development team focused on research, development, existing product support and bringing to market medical devices to support Merz business objectives. The successful candidate will be involved with projects covering all aspects of product development includingconcept, design, verification testing and transfer to manufacturing.



Responsibilities:


  • Electrical engineering design, development and support of products, sub-assemblies, board level circuits with a strong emphasis on analog-based circuits including implementation of HIFU amplifiers, linear regulators and buck power supplies.

  • Verify design requirements through engineering analysis and testing.

  • Write and conduct engineering studies for root cause analysis on product enhancements and failures.

  • Lead system integration and verification test planning using high-level verification test plans.

  • Provide broad electrical engineering technical expertise through various phases of product life cycle.

  • Provide engineering analysis, feasibility reports and studies to assist the product development team.

  • Provide electrical engineering support ensuring current and new products meet Medical Device safety requirements such as IEC 60601 and other Medical Device standards.

  • Maintain/improve existing product designs in support of manufacturing activities.

  • Follow design control procedures and enhance existing procedures as needed.

  • Lead root cause investigations for product quality issues and implement correction plans.

Education:


  • Bachelors degree in Systems, Electrical Engineering, or a related field.

  • Masters degree in Systems, Mechanical, Electrical Engineering, or a related field preferred.

Professional Experience:


  • Minimum of 5 years of engineering experience in the medical device industry.

  • Proven experience in analog design completing board level and product designs with analog circuits. Specific experience in board-level power supplies, HIFU power amplifiers, high power frequency generation using DDS synthesizers, filters, and wave shaping.

  • Full development lifecycle experience (concept to commercialization) with at least one medical device.

  • Experience collaborating with design partners/contract engineering firms to design and develop a medical device.

  • Experience with oversight of contract test agencies, including problem resolution, for standardized testing.

  • Experience with medical devices with integrated software, hardware, and firmware.

  • Experience with IEC 60601-1 and -2 Medical Device Safety testing.

  • Experience with on FDA QSR (21 CFR 820), ISO 13485, ISO 14971.

  • Exposure to software development practices and IEC 62304.

  • Demonstrated ability to author and manage systems, sub-assembly and board level requirements and specifications in a highly methodical and organized manner.

  • Strong comprehension of risk management and risk analysis techniques, consistent with ISO 14971, applied to medical devices.

  • Thorough understanding of Design Controls (e.g. 21 CFR 820:30).

  • Thorough understanding of verification strategy and test planning.

Knowledge of methods:


  • Experience with engineering analysis tools such as MatLab and Signal Integrity tools, Hyperlinx or other similar tools.

  • Experience with Orcad, Cadence Allegro, PADs schematic and layout tools or equivalent.

  • Experience with analog board level design for frequency generation, power amplifiers, harmonic filter suppression, wave shaping, and mixed signal technology designs.

  • Very good understanding of high-speed layout considerations such as parasitic, crosstalk isolation, power supply noise, grounding and EMI consideration.

  • Experience with circuit modeling tools such as Pspice, Hspice or equivalent.

  • Experience with designs containing FPGAs.

  • Familiarity with common manufacturing methods, both for electrical and mechanical and components.

Interpersonal skills:


  • Demonstrated ability to deliver results with minimal supervision in a timely manner.

  • Ability to collaborate, communicate and coordinate cross-functionally.



Research and Development





Posted: 2021-06-09 Expires: 2021-07-08
Sponsored by:
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Senior Electrical Engineer

Merz North America, Inc
Mesa, AZ 85201

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