Lead Electrical Engineer, R&D

The Lead Electrical Engineer designs, develops, modifies and evaluates components and processes used in the generation, manipulation, transmission and storage of electricity within Breast & Skeletal Health products. This individual determines design approaches and parameters. Uses and analyzes equipment to establish operating data, conducts experimental tests and evaluates results. Interacts with users to define system requirements and/or necessary modifications.

The Lead Electrical Engineer works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results. Networks with key contacts outside own area of expertise.

The Lead Electrical Engineer has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Determines methods and procedures on new assignments and coordinate activities of other personnel as a Team Lead.

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.

• Maintain and expand on an expert level of understanding of our products and their use in clinical practice to design, develop and test our next generation products. Promotes and contributes to the development of product knowledge throughout the organization.
• Functions in a technical leadership role and can effectively coordinate and lead simultaneous programs or projects of varying sizes. Coordinates work activities and supports personnel to meet project objectives.
• Participates in product and cross functional product and project teams.
• Represents Electrical Engineering and department culture through example, leadership and excellent communication skills.
• Owns architectural specifications of electrical and electronic systems and subsystems for medical device development.
• Performs and guides lower-level engineers in electrical design, design reviews, design transfers, design changes, process changes, design for manufacturability, and product enhancements including related testing, tooling, and fixtures.
• Ensure the design requirements are met and methods/processes are developed, tested, and executed per medical device design control process and which supports all design control and quality standards.
• Contributes and directs engineers in performing design responsibilities such as design, analysis or trouble shooting of printed circuit assemblies, cable and harnessing design, power conversion circuits, analog conversion, filtering circuits, power distribution, and developing CAD schematics for electrical assembly or PCB design.
• Significant contributor to the creation of specifications and schedules, manages the progression of tasks to prevent electrical design from gating other functions. Works with transparency reporting on progress resolving issues to avoid business impact.
• Develop schematic in Cadstar or OrCAD for electrical design and work with various PCB layout tools (Cadstar, PADS, OrCAD Allegro, Altium) for PCB development.
• Analyze, design, test and study feasibility of subsystems, assemblies, and their components to identify opportunities for design, cost or time-to-market improvements.
• Contributes or directs 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.
• Accountable for the identification, diagnosis, prioritization, and correction of complex technical issues. Launch processes leveraging cross functional teams to review quality problems and determine root cause. Implement and track solid corrective actions to reduce defects and failures.
• Actively supports and adheres to the Quality Policy, Quality System procedures and department Best Practice Guidelines. Helps to standardize policies, procedures and standards incorporating internal and industry best practices.
• Accountable for the creation, review, correction, enhancement of drawings and documentation to meet or exceed internal and external requirements. Must maintain design and configuration control for all manufactured products assigned.
• Is a change agent and drives a culture of continuous learning and improvement. Champions opportunities to introduce new technologies, systems, methods, and controls and deliver design, quality, cost or time-to-market improvements.
• Identify and lead complex projects that drive meaningful improvements with a significant positive impact on product quality and performance and manufacturing efficiency and costs.
• Establish collaborative relationships with all stakeholders within the division and create links with experts within the network and outside.
• Continue professional development by channeling interests and development needs to seek out opportunities to learn and grow within the company.
• Train and mentor lower-level engineers to further develop and impact the organization.

  Qualifications:

  Education

• Preferred Minimum Non-Technical Degree: College Degree
• Preferred Minimum Technical/Advanced Degree: Master’s Degree

  Experience

• Preferred Minimum Non-Technical Degree: 8+ Years
• Preferred Minimum Technical/Advanced Degree: 6+ Years with Master’s Degree, 3+ Years with PhD

  Skills

  Desired:
  • In-depth theoretical and practical knowledge of AC and DC motors, power stage design, gate drivers, brake circuit, feedback, current sensing and protection circuitry.
  • Specialized in BLDC and Stepper motor control designs, develops, and tests motor systems by integrating various encoders for precision feedback.
  • In-depth knowledge of electronic design, medical device design, analog/digital circuit design, PCB design, PCB and PCBA manufacturing processes.
  • Experience working in medical devices or other highly regulated industry.
    • Advanced knowledge of MS Office, schematic capture and CAD tools for PCB layout and design.
    • Ability to design at all levels; Advanced troubleshooting, testing, and debugging skills.
    • In depth knowledge and experience working the full product life cycle for electrical/electronic products.
    • Proficiency with laboratory test equipment such as multi-meters, oscilloscopes, spectrum analyzers, function generators, logic analyzers, etc.
    • In depth knowledge of IEC 60601-1 and 60601-1-2 technical standards, ISO 13485 and 21CFR Part 820, ISO 14971 Risk Management and EMC standards
    • Excellent written, verbal, and interpersonal skills. Adapts communication style to suit different audiences. Creates precise, accurate technical documentation. Able to facilitate brainstorming, Root Cause, Root Cause Failure Analysis Methodologies, and other group discussions.
    • Ability to efficiently direct and coordinate the work of others.
    • Demonstrated ability to lead, mentor and coach other engineers.
    • Ability to analyze a situation or data; evaluate relevant identifiable factors and translate information into a meaningful proposal or action plan.
    • Agile Product Development Lifecycle Management is beneficial.
    • Ability to write embedded code to test designs is beneficial.

      Physical Demands:

      The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

      ? Sit; use hands to finger, handle or feel objects, tools, or controls.

      ? Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.

      ? Lifting/moving and carrying products weighing up to 40 pounds.

      ? Exposure to moving mechanical parts, vibration and/or moderate noise levels.

      ? Exposure to hazardous chemicals or other materials.

      ? Safety Shoes with Impact and Compression Protection Must be worn in designated areas.

      ? Travel (please specify): <10%

      ? Other (please specify): Exposure to Ionizing Radiation. Follow training guidelines.

      Must follow all applicable FDA regulations and ISO requirements.