Senior Staff Engineer, Manufacturing Engineering

Reposted 5 Hours Ago
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Cork
In-Office
Senior level
Healthtech • Other • Robotics • Biotech • Manufacturing
Together with our customers, we're on a mission to make healthcare better.
The Role
The Senior Staff Engineer will develop and implement automation solutions in manufacturing, lead cross-functional teams, and support operational efficiency for neurovascular products.
Summary Generated by Built In
Work Flexibility: Hybrid

Position Summary 

 

The Senior Staff Engineer will drive a culture of automation, innovation, and continuous improvement to support the Neurovascular product portfolio. The engineer will have a deep technical expertise, be a strategic thinking, and have strong leadership capabilities to develop and implement solutions that enhance our operational efficiency and product quality.

The Engineer will work closely with cross-functional teams—including Manufacturing, R&D, Quality, and Regulatory Affairs—to deliver reliable, validated automation solutions that support scalability and compliance.

This position requires both hands-on technical expertise and strong project management skills to bring innovative automation solutions from concept to production within a highly regulated environment.

Key Areas of Responsibility

  • Oversee automation projects from conception to execution, ensuring alignment with organizational goals.

  • Contribute and input into Engineering functional strategy.

  • Collaborate with cross-functional teams to identify automation opportunities and prioritize initiatives.

  • Be a Technological expert, willing to source, investigate and implement technological and automation advances.

  • Lead design, development, testing & refinement of automated system, sub-system & component.

  • Support the implementation of automation strategies across projects.

  • Technical leadership of Staff engineers, Senior engineers, Engineers, Coop students, and Technicians.

  • Co-ordinates with other unit’s vendors and senior managers as needed to ensure specific cost, time, and regulatory standards achieved.

  • Communicates with business partners to resolve process and product issues.

  • Champion operations excellence across the site

Qualifications / Knowledge/ Skills
  • Degree or Masters in relevant Engineering or Science discipline (Manufacturing, Mechanical, etc) or technical experience equivalency.

  • Minimum of 6 years’ experience.

  • Recognised Lean qualification, ideally a black belt.

  • Experience with medical device manufacturing processes (e.g., cleanroom automation, micro-assembly, automated testing).

  • Technological expert, willing to source, investigate and implement technological and automation advances.

  • Proven Project Management skills through the delivery of business-critical projects.

  • Confident and effective decision maker, with a proven technical leadership ability to negotiate and influence others.

  • Effective technical documentation and change control in regulated environments.

  • Excellent cross-functional collaboration with Manufacturing, Quality, and R&D teams.

  • Capable of technically leading a multi-disciplined team in a dynamic, regulated and results motivated environment.

  • Demonstrable Excellent analytical & critical thinking skills, a process improvement orientation.

  • Demonstrable ability to lead significant projects and initiatives.

  • Familiarity with GAMP 5 and computer system validation (CSV) for automated equipment.

  • Understanding of ISO 13485, ISO 14971, and FDA 21 CFR Part 11 compliance in automation systems.

  • Experience with integration of MES/ERP systems for manufacturing data traceability.

  • Proficient in CAD tools for fixture and tooling design (SolidWorks or similar).

#IJ

Travel Percentage: 10%

Top Skills

Cad Tools
Computer System Validation
Erp
Fda 21 Cfr Part 11
Gamp 5
Iso 13485
Iso 14971
Mes
Solidworks
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The Company
HQ: Kalamazoo, MI
51,000 Employees
Year Founded: 1941

What We Do

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com.

Together with our customers, we are driven to make healthcare better.

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