Sr Automation Engineer I

Starkey is adding a Sr. Automation Engineer - Onsite at its global headquarters in Eden Prairie, MN. If you have strong automation leadership collaborating with cross functional teams within manufacturing, this could be your next opportunity. As a Sr. Automation Engineer I in the medical device industry, you will serve as a subject-matter expert in the design, development, optimization, and deployment of advanced automation solutions that support the assembly and testing of regulated medical products. You will lead high-impact automation initiatives and ensure compliance with FDA and ISO 13485 standards.  

Starkey is a world leader in the manufacturing and distribution of advanced hearing technologies. We are in the business of connecting people and changing lives. Our teams come to work each day focused on ensuring people everywhere have the products and services they need to hear better and live better. Founded in 1967 by Bill Austin, Starkey is known for our cutting-edge hearing health innovations, industry-leading research and development, and not being afraid to push the edge of what’s possible. We are headquartered in Eden Prairie, Minnesota, have over 5,000 employees in 29 facilities across the globe, and do business in more than 100 markets worldwide.

Watch this video to see more of what sets Starkey apart.

https://youtu.be/9cUYwTlCepg?si=wkovx8_R_iINfrc6

JOB RESPONSIBILITIES

Design & Development:

• Develop and implement automated manufacturing solutions for small-scale medical components
• Collaborate with cross-functional teams and automation integrators to design tooling, fixtures, and robotic solutions
• Integrate sensors, vision systems, and PLC’s into automation platforms

Process Optimization:

• Analyze existing manufacturing processes and identify high impact opportunities for automation and efficiency improvements
• Conduct time studies, root cause analysis, and continuous improvement initiatives
• Support lean manufacturing and Six Sigma efforts

Validation & Compliance:

• Ensure all automation systems comply with FDA, ISO 13485, and other relevant medical device regulations
• Author, review, and execute IQ/OQ/PQ protocols for automated equipment
• Maintain comprehensive documentation for traceability and audit readiness

Project Management:

• Lead automation projects from concept through deployment ensuring alignment with business goals
• Manage timelines, budgets, and vendor relationships
• Provide training and support to production and maintenance teams
• Drive process improvement ideas and actively participate in continuous improvement projects
• Actively pursue cost savings initiatives
• Mentor Jr Engineers and support knowledge transfer across the organization
• Perform other duties/responsibilities as assigned

JOB REQUIREMENTS
Minimum Education and Experience Requirements

• Education 
  • Bachelor's degree in electrical, mechanical, automation or controls engineering
• Experience 
  • 7 years of automation engineering experience preferably in medical device or precision manufacturing

Knowledge / Technical Requirements

• Knowledge of PLC programming (e.g., Allen-Bradley, Siemens), HMI development, and industrial robotics
• Knowledge of technical design required
• Knowledge of geometrical tolerance required
• Strong understanding of GMP, FDA, and ISO standards

Competencies, Skills & Abilities

• Planning and Execution
  • Strong skills in project scoping, scheduling, budgeting and resource allocation
  • Familiarity with project management tools (ex. MS Project or Smartsheet)
• Cross-Functional Collaboration
  • Ability to work with R&D, Quality, Manufacturing, and external vendors
  • Skilled in leading design reviews and technical discussions
  • Excellent problem solving, communication, and project management skills

• Experience with CAD software (SolidWorks, AutoCAD, CREO) and machine vision systems to support project concepts

WORK CONTEXT

Working Conditions 

• Standard office conditions
• Some travel required

Equipment Operation 

• Standard office equipment
• Test Equipment, CREO, MS Office, machine shop tools and measuring equipment, 3D Printers, Laser-marking equipment

Salary and Other Compensation:  

The target rate for this position is between $XXX to $XXX year.  Factors which may affect starting pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate.  

Benefits:  
The following benefits for this position, subject to applicable eligibility requirements, include medical, dental, and vision insurance, 401(k) retirement plan with company match, company-paid life insurance, short-term disability insurance, long term disability insurance, employee assistance program, hearing aid benefits, paid time off, paid sick time, and paid holidays.

This position is eligible for a bonus based upon performance results. There is no guarantee of payout.

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