Starkey Hearing · 2 weeks ago
Sr Automation Engineer I - Onsite
Eden Prairie, MN
Full-time
Onsite
Mid, Senior Level
$94K/yr - $150K/yr
7+ years expStarkey Hearing is a world leader in the manufacturing and distribution of advanced hearing technologies. As a Sr. Automation Engineer I, you will lead high-impact automation initiatives in the medical device industry, ensuring compliance with FDA and ISO standards while collaborating with cross-functional teams to optimize manufacturing processes.
Health CareMedical DeviceWellness
Hiring Manager
Kelly Sheppard
Responsibilities
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
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
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
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
Qualification
Required
Bachelor's degree in electrical, mechanical, automation or controls engineering
7+ years of automation engineering experience preferably in medical device or precision manufacturing
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
Strong skills in project scoping, scheduling, budgeting and resource allocation
Familiarity with project management tools (ex. MS Project or Smartsheet)
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
Benefits
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
Paid holidays
Company
Starkey Hearing
Starkey is a privately held, global hearing technology company headquartered in Eden Prairie, Minnesota, USA.
5001-10000 employees
H1B Sponsorship
Starkey Hearing has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
2024 (10)
2023 (14)
2022 (28)
2021 (23)
2020 (35)
Funding
Current Stage
Late StageLeadership Team
Brandon Sawalich
President & CEO
Recent News
2025-12-15
Medical Product Outsourcing
2025-12-05
2025-11-07
Company data provided by crunchbase