The Electrical Engineer will provide electrical and software engineering for the product development team compliantly within the company Quality Systems, 21 CFR 820.30, and ISO 13485.
- With strong collaboration among all department leaders, provide technical leadership to the organization with a focus on design engineering.
- Maintain a positive, high performance environment that fosters extraordinary customer satisfaction and associate retention.
- Recommend improvements to and maintain compliance to the Quality System, 21 CFR 820.30, and ISO 13485.
- Participate in internal and external FDA, ISO 13485, and customer audits as required.
- Provide engineering solutions to meet global product safety standards.
- Provide electrical and software engineering execution of multiple complex projects from design, prototype, pilot production and transition to manufacturing.
- Provide Engineering Solutions using Best Practices and Policies consistent with company goals and objectives in an open and collaborative manner.
- Reinforce and encourage company core values.
- Provide professional and technical assistance and guidance to associates and customers.
- Support the development of detailed proposals and SOW’s for electrical and software engineering services.
- Execute software engineering compliant to software design controls.
- Execute electrical engineering compliant to medical device product safety regulations such as IEC 60601-1 and EMC safety regulations such as IEC 61000-x-x.
- Provide engineering services such as work instruction development, tooling and fixture design.
- Other responsibilities as directed.
- Positive attitude, excellent communications skills, self-motivator, tenacious follow up, and superior organization skills.
- Superior customer service attitude.
- BS Degree in electrical engineering. MS preferred.
- Minimum of 4 years of experience in medical device product development required.
- Direct experience working within design controls (21 CFR 820.30) processes required.
- Excellent negotiation, problem solving, and written and oral communication skills, including experience presenting to customers and internal senior management.
- Excellent organizational skills with a commitment to meeting deadlines and expectations while ensuring overall compliance and quality of delivery.
- Excellent technical, problem solving and analytical abilities.
- Strong quality mindset a must.
- Must be flexible, possess strong leadership and interpersonal communication skills; ability to manage multiple priorities.
- Strong decision making capabilities and capacity to handle confidential information.
- Experience in phase gate product development required.
- A demonstrated commitment to company values.
- Proficient in Microsoft Office.
- Proficient with OrCAD schematic capture. PADS PCB layout is a plus.
- Proficient in C, C++, Visual C++, Basic, Visual Basic, Assembler software languages.
- Proficient in Windows, Windows CE, Unix operating systems.
- Proficient in RS232, USB, I2C, SPI, Parallel Bus protocols.
- Proficient in analog and digital circuit design, FPGA’s, Embedded Control Systems, High Voltage, Power Supply circuits.
- Laser experience is a plus.