Electrical Manufacturing Engineer III - Medical Device

Electrical Manufacturing Engineer III - Medical Device

Base pay range: $/yr - $/yr

Responsibilities

• Solving complex problems and implementing innovative solutions.

• Executing detailed root cause analysis and recommending vetted solutions.

• Communicating and explaining problems and solutions cross‑functionally and interdepartmentally.

• Collaborating closely with suppliers, ensuring timely communication of updates and respectfully requesting any necessary changes.

• Engaging in troubleshooting of electromechanical products using failure analysis and problem‑solving techniques, while recommending and implementing effective solutions.

• Leading the implementation of projects at the supplier level, managing communications related to test plans, monitoring project timelines, and ensuring all milestones are met efficiently.

• Approaching problems from a detail‑oriented perspective.

• Suggesting independent recommendations for project approach, scope, and tactics.

• Supporting production: creating and maintaining product and process documentation; monitoring process and equipment performance and identifying and implementing process improvement activities to increase/optimize yield, efficiency, and/or throughput.

• Designing fixtures, acquiring off‑the‑shelf tooling and equipment, and implementing new fixturing on the production line; performing equipment qualifications.

• Testing processes, equipment, raw materials, and product; performing process validations; authoring protocols to execute tests, writing reports, and making conclusions and/or recommendations based on test results.

• Planning, scheduling, conducting, and coordinating detailed phases of engineering work as part of a project or as a total project.

• Developing specifications of a product, process, or piece of equipment.

• Developing, characterizing, and optimizing processes using statistical techniques and engineering knowledge and experience.

• Coordinating with the appropriate suppliers and other external resources needed in developing and implementing process improvement plans.

• Participating in project planning and scheduling.

• Training assemblers, quality control and technicians, as necessary, on processes, equipment, and documentation.

• Performing other activities requiring knowledge of principles and techniques commonly employed in the specific area of projects.

• Adhering to the company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.

• Understanding relevant security, privacy and compliance principles and adhering to the regulations, standards, and procedures that are applicable to the company.

• Ensuring other members of the department follow the QMS, regulations, standards, and procedures.

• Performing other work‑related duties as assigned.

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering or a related field with 2+ years relevant engineering experience, or an equivalent combination of education and experience.

• Engineering experience in a manufacturing environment recommended; medical device industry preferred.

• Experience with electronic devices and/or PCBA.

• Experience with contract manufactured electromechanical medical device products.

• Excellent written, verbal, and interpersonal communication skills required; leadership skills desired.

• Knowledge of FDA regulations, Lean/Flow Manufacturing, and/or materials and manufacturing processes desired.

• Proficiency in Word, Excel, PowerPoint, Access, and other computer applications required.

Location and Salary

Alameda, CA

Annual base salary: $109,000 to $152,000

Working Conditions

• General office, laboratory, and clean room environments.

• Willingness and ability to work on site.

• Business travel from 0% – 10%.

• Potential exposure to blood‑borne pathogens.

• Requires some lifting and moving of up to 25 pounds.

• Must be able to move between buildings and floors.

• Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.

• Must be able to read, prepare…