Sr Electrical Engineer

Compensation

: $105,050.00 - $162,390.00 /year *

Employment Type

: Full-Time

Industry

: Scientific Research



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This individual will be an important member of the Merz Product Development team focused on research, development, 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 including concept, design, verification testing and transfer to manufacturing.

Understanding and application of electrical engineering principles for medical device design. Ability to lead electrical design and development; responsible for electrical engineering of new and current systems in the R&D Product Development teams. Ability to set priorities based on project and business needs. Work well in a team environment to ensure that product design, schedule and quality goals meet the business needs.

ESSENTIAL DUTIES AND RESPONSIBILITIES
  • Provide broad electrical engineering technical expertise and product development knowledge through various phases of product life cycle.
  • Verify that designs meet functional requirements through the performance of engineering analyses and testing.
  • Leads system integration and verification test planning process and the creation of a high-level verification test plan.
  • Electrical engineering design and development of products, components, board level circuits.
  • Provide engineering analysis and feasibility reports and studies to assist a cross-functional product development team.
  • Analyze product failures to circuit board and component level and report on root causes with written reports.
  • Provide electrical engineering support to ensure existing and new products meet Medical Device safety requirements such as IEC 60601 and other Medical Device requirement standards.
  • Maintains/improves existing product designs in support of Manufacturing activities.
  • Follow Design Control procedures and contribute to enhancing existing procedures as needed.
  • Leading root cause investigations for the resolution of product quality problems and implements correction plans to prevent quality issues from re-occurring.
KNOWLEDGE, SKILLS, AND ABILITIES
  • Demonstrated ability to author and manage systems, sub-assembly and board level requirements and specifications in a highly methodical and organized manner. - Required
  • Strong comprehension of risk management and risk analysis techniques, consistent with ISO 14971, applied to medical devices. - Required
  • Thorough understanding of Design Controls (e.g. 21 CFR 820:30). - Required
  • Thorough understanding of verification strategy and test planning. - Required
KNOWLEDGE OF METHODS
  • Experience with engineering analysis tools such as MatLab and Signal Integrity tools, Hyperlinx or other similar tools. - Required
  • Experience with Orcad, Cadence Allegro, PADs schematic and layout tools or equivalent. - Required
  • Very good understanding of high-speed layout considerations such as parasitic, crosstalk isolation, power supply noise, grounding and EMI consideration. - Required
  • Experience with circuit modeling tools such as Pspice, Hspice or equivalent. - Required
  • Familiarity with common manufacturing methods, both for electrical and mechanical and components. - Required
  • Experience with designs containing FPGAs. - Preferred
EDUCATION
  • Bachelor s degree in Systems, Electrical Engineering, or a related field. - Required
  • Master s degree in Systems, Mechanical or Electrical Engineering, or a related field. - Preferred
PROFESSIONAL EXPERIENCE
  • Minimum of 5 years of engineering experience in the medical device industry. - Required
  • Full development lifecycle experience (concept to commercialization) with at least one medical device. - Required
  • Experience collaborating with design partners/contract engineering firms to design and develop a medical device. - Preferred
  • Experience with oversight of contract test agencies, including problem resolution, for standardized testing. - Preferred
  • Experience with medical devices with integrated software, hardware, and firmware. - Required
  • Experience with IEC 60601-1 and -2 Medical Device Safety testing. - Required
  • Experience with on FDA QSR (21 CFR 820), ISO 13485, ISO 14971. - Required
  • Exposure to software development practices and IEC 62304. - Preferred
  • Excellent verbal and written communication. - Required
  • Proficient with Word, Excel, PowerPoint, and Project. - Required
Requirements
  • Minimum of 5 years of engineering experience in the medical device industry.

Associated topics: chip, c++, java, linux, matlab, photonics, programmer, programming, robotics, software * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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