Senior Automation Engineer Aesthetic Medical Device (Bothell, WA)

About the role

The Senior Automation Engineer leads the design, development, validation, and implementation of automation systems and equipment to support manufacturing operations. This role ensures product quality, delivery efficiency, and cost optimization while driving continuous improvement in automated processes.

Responsibilities

• Own and execute site-let automation projects end-to-end; serve as Solta technical owner for integrator-led automation projects (URS/specs, design reviews, FAT/SAT, acceptance).
• Develop and drive best practices around automation equipment design principles and standards.
• Set Design for Automation (DFA) requirements and work with Product Development to ensure manufacturability of products.
• Hold design reviews and ensure DFA requirements are met.
• Collaborate with stakeholders (manufacturing and test engineers, technicians, operators) to develop and execute semi-automation or partial automation projects.
• Develop and execute process and equipment verification and validation (IQ/OQ/PQ) plans, reports, and associated documentation (requirements, SOPs, training, change control).
• Develop and implement optical inspections to ensure quality processes.
• Create and provide requirements to vendors for quoting equipment.
• Perform Gage R&R analysis on new products and processes.
• Initiate root-cause analysis and troubleshooting of deployed automation to improve OEE/yield and reduce cost.
• Consult with leadership on overall automation strategy.
• Provide technical leadership and mentorship to manufacturing engineers.
• Act as site automation technical authority.
• Identify and justify automation projects across labor, quality, risk, and capacity drivers.

Requirements

• BS in Mechanical Engineering or Electrical Engineering, related field, or equivalent experience.
• Minimum 5 years of experience designing, developing, or implementing automated equipment/systems in a manufacturing or industrial environment.
• Proven Project Management skills through the delivery of business-critical projects.
• Proficiency in automation technologies, industrial and collaborative robotics, and vision systems.
• Demonstrated ability to set up manufacturing lines and processes.
• Experience assessing process variables utilizing a process failure modes effects analysis (PFMEA).
• Demonstrated ability to verify and validate production processes and equipment (IQ/OQ/PQ, FAT, SAT).
• Demonstrated ability to drive production process improvement through equipment, methods, and design.
• Demonstrated ability to utilize SPC and design of experiments to drive change.
• Demonstrated ability to drive DFA improvement into product designs during development.
• Demonstrated ability to utilize and implement lean manufacturing concepts.
• Experience with Creo or other CAD solid modeling tools.
• Strong PC skills required – Word, Excel, PowerPoint, etc.

Qualifications

• Experience in a capital equipment medical device manufacturing environment.
• Working knowledge of medical device FDA QSR’s and ISO 9001 requirements.
• Experience with PLC programming.
• Background in RF and laser equipment and/or diagnostic or therapeutic ultrasound.
• Language and verbal skills: Ability to read, analyze, and interpret engineering specifications, general business periodicals, professional journals, technical procedures, or governmental regulations; ability to write reports, specifications, business correspondence, and procedure manuals; ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public; ability to clearly and concisely convey project accomplishments, obstacles, issues, and status to project team members.
• Math skills: Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry; ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations; ability to use MS Excel or Minitab to perform calculations and interpret project results/data.
• Physical requirements: While performing the duties of this job, the employee may be required to perform lifting tasks of up to 30 pounds for short durations. Duties of this job may involve standing and/or walking for extended periods of time. Duties also involve daily keyboard data entry.

Desired skills

• Experience in a capital equipment medical device manufacturing environment.
• Working knowledge of medical device FDA QSR’s and ISO 9001 requirements.
• Experience with PLC programming.
• Background in RF and laser equipment and/or diagnostic or therapeutic ultrasound.

Benefits

• Comprehensive Medical (includes Prescription Drug), Dental, Vision, Flexible Spending Accounts, 401(k) with matching company contribution, discretionary time off, paid sick time, stock purchase plan, tuition reimbursement, parental leave, short-term and long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, employee referral bonuses and employee discounts.