Contract Senior Design Manager Jobs in Delaware (NOW HIRING)

The Senior Electrical Engineer designs, develops, modifies and evaluates components and processes used in the generation, manipulation, transmission and storage of electricity. Determines design approaches and parameters. Analyzes equipment to establish operating data, conducts experimental tests and evaluates results. Selects components and equipment based on analysis of specifications and reliability. Completes documentation and procedures for installation and maintenance. May interact with users to define system requirements and/or necessary modifications.

The Senior Electrical Engineer works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise. This individual is a seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is a fully qualified, career-oriented, journey-level position. Normally receives little instruction on day-to-day work, general instructions on new assignments.

Essential Duties and Responsibilities:

• The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
• Develop an expert level of understanding of our products and their use in clinical practice to design, develop and test our next generation diagnostic systems.
• Builds relationships with other team members and functions such as program management, field service, manufacturing, mechanical, compliance, reliability, or design engineers.
• Represents Electrical Engineering and department culture through example, leadership and excellent communication skills.
• Performs and provides technical guidance in the design process, including providing innovative, detailed design solutions, design transfer from R&D to sustaining and leading design reviews.
• Leads and performs design responsibilities such as design, analysis or trouble shooting of printed circuit assemblies, cable and harnessing design, power distribution, and developing CAD schematics for electrical assembly or PCB design.
• Accountable for the identification, diagnosis, prioritization, and correction of complex technical issues. Supplies technical support for manufacturing and services issues using a systematic approach and providing effective solutions.
• Responsible for the specification, selection, and testing of hardware, electronic and electro-mechanical components. Performs or guides other engineers in activities to develop, build and maintain electrical test fixtures, prototypes, test control apparatus and equipment. Determines methods, procedures and conditions for testing the engineered products and associated apparatus.
• Works with contract manufacturers and vendors/suppliers to ensure device design and parts meet functionality and medical device quality and regulatory standards.
• Responsible for the creation of design documents and supporting documentation such as CAD package updates, design requirements, specifications, verification procedures or reports, engineering change notices.
• Actively supports and adheres to the Quality Policy and Quality System procedures.
• Ensures design, fabrication, maintenance, and repair methods/processes are developed as well as executed in a manner which supports all quality standards.
• Creates schedules, track tasks and works with transparency reporting on progress and highlighting success factors such as progress, schedule, budget, project risks and resource or needs gaps.
• Identify and participate in meaningful improvements positively impacting product quality and manufacturing efficiency. Contributes to CAPA, VIP, cost reduction, EOL and other projects.
• Establish collaborative relationships with all stakeholders within the division and create links with experts within the Hologic network and outside.
• Continue professional development by channeling interests and development needs and seeking out opportunities to learn and grow within the company.
• Manage several projects and priorities concurrently, with limited guidance, as defined by program or functional management.
• Mentor less senior engineers.
• Be a change agent driving improvement daily.

Experience

• Preferred Minimum Non-Technical Degree: 5-8 Years
• Preferred Minimum Technical/Advanced Degree: 2-5 Years with Technical Bachelor’s Degree, 1-3 Years with Master’s Degree, 0-1 Years with PhD
• Experience in an FDA regulated medical device industry is beneficial.
  

Skills

• Advanced knowledge of MS Office and CAD tools , such as Mentor Graphics, CADSTAR, OrCAD, Altium or equivalent, for schematic capture/PCB design.
• Thorough understanding of electronic design, medical device design, analog/digital circuit design, PCB design, PCB and PCBA manufacturing processes, software, optics, and human factors
• Ability to design at a complex level; Ability to test systems and subsystems in both analog and digital electronics; Ability to test and debug moderate complexity electronic designs to a component level; Ability to perform hands on fabrication, testing, and repair work.
• Knowledge and experience working through full product lifecycle.
• Proficiency with laboratory test equipment such as multi-meters, oscilloscopes, spectrum analyzers, function generators, logic analyzers, etc.
• Experience working with various sensors and micro-controllers/processor-based designs for medical device development (e.g. DDR Memory, Serial Flash, and serial interfaces- CAN I2C, SPI, UART, USB and RS232)
• Knowledge of IEC 60601-1 and 60601-1-2 technical standards, ISO 14971 Risk Management and EMC standards
• Excellent written, verbal, and interpersonal skills with ability to lead and motivate a project team.
• Strong contributor to high performing team. Demonstrated ownership in executing project deliverables.
• Advanced ability to create and manage documentation according to design control procedures.
• Thorough understanding of Design for Manufacturability (DFM), Root Cause, Root Cause Failure Analysis Methodologies, Failure Mode and Effect Analysis (FMEA)
• Agile Product Development Lifecycle Management is beneficial.
• Knowledge of motor control, design simulators, high voltage, detector imaging, x-ray design, Verilog or VHDL design, is beneficial.
• Ability to write embedded code to test designs is beneficial.

  Must follow all applicable FDA regulations and ISO requirements