Principal Hardware & Firmware Engineer - Merz North America, Inc

This individual will be an important member of the Merz Product Development team focused on research, development of electrical hardware and associated embedded firmware and future products, bringing to market medical devices to support Merz, business objectives. The successful candidate will be involved with projects covering all aspects of electrical and firmware development including concept, design, verification testing and transfer to manufacturing.

Responsibilities 

• Properly plan and execute scheduled electrical and firmware work packages collaborating with internal and external design resources to meet project milestones
• Model delivering electrical and firmware products in a timely fashion with integrity and meeting all applicable standard for medical device quality.
• Ensure duties are completed according to Merz SOPs and enhance necessary SOPs to improve efficiency and quality.
• Responsible for electrical engineering design, development and support of products, sub-assemblies, board level circuits with a strong emphasis on digital and some analog based circuits containing HIFU amplifiers, linear regulators and buck power supplies.
• Write and develop associated firmware designs to support hardware functionality. Experience in FPGA and Micro Controller designs and able to write in Verilog and VHDL code.
• Responsible for verifying electrical and firmware design requirements through engineering analysis and testing.
• Write and conduct engineering studies for root cause analysis on product enhancements and failures.
• Complete system integration and verification test planning using high-level verification test plans.
• Provide broad electrical and firmware engineering technical expertise through various phases of product life cycle.
• Provide electrical and firmware engineering analysis, feasibility reports and studies to assist the product development team.
• Provide electrical and firmware 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

• Bachelor’s degree in Systems, Electrical Engineering, or a related field.

Professional experience

• 12+ year total Electrical Engineering experience                                                                                
• 7+ years of engineering experience in the medical device industry and/or highly regulated engineering environments.
• 5+ years of proven experience in mixed signal designs utilizing FPGAs. 
• 5+ years experience using FPGAs in hardware designs. Fluent in Verilog and VHDL FPGA design languages and FPGA simulation.
• 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.
• Excellent verbal and written communication.
• Proficient with Word, Excel, PowerPoint, and Project.
• Demonstrated ability to deliver results with minimal supervision in a timely manner.
• Ability to collaborate, communicate and coordinate cross-functionally.

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.
• Expert level FPGA designer in Verilog
• Strong comprehension of risk management and risk analysis techniques, consistent with ISO 14971, applied to medical devices.
• Thorough understanding of verification strategy and test planning.
• Experience with Altera, Xilinx or Lattice FPGA development environments.
• 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 mixed signal technology designs.
• Very good understanding of high-speed layout considerations such as parasitic, crosstalk isolation, power supply noise, grounding and EMI consideration.
• Familiarity with common manufacturing methods, both for electrical and mechanical and components.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) Research and Development