Director of Engineering

Job Description

Permanent, Director of Engineering, Combination Products
Summary
Our client, a small, growing medical device organization, has engaged GForce Life Sciences to provide a Director of Engineering. This role combines people leadership, technical authority, client engagement, and operational ownership. The ideal candidate has deep experience developing drug-device combination products and can lead teams working across autoinjectors, pen injectors, prefilled syringes, on-body/wearable injectors, infusion systems, and related delivery platforms.\n
\nThis is a hands-on leadership role for someone who can set technical direction, develop engineers, strengthen laboratory execution, and serve as a credible technical partner to clients from early development through verification, validation, investigation, and design-history-file execution.\n
Job Duties
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• Manage and develop an engineering team, setting clear priorities and performance expectations while providing technical coaching, feedback, and resource direction.
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• Oversee programs involving medical devices and combination products, including requirements development, test-method development and validation, design verification and validation, failure analysis, and design history file support.
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• Provide senior engineering review and approval of protocols, reports, test procedures, investigation findings, deviations, design inputs, and risk documentation.
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• Improve laboratory execution through stronger testing practices, equipment readiness, documentation, and workflow efficiency. Apply sound engineering principles and statistical methods to support consistent, reliable results.
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• Collaborate with Quality and Operations to coordinate equipment qualification, calibration, preventive maintenance, and laboratory readiness.
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• Serve as a technical resource for clients, helping define project objectives, evaluate development strategies, communicate risks, and resolve challenging engineering questions.
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• Contribute to business growth through technical project scoping, proposal development, evaluation of new service opportunities, and client relationship support.
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• Guide structured investigations and continuous improvement efforts to address technical issues, identify root causes, and prevent recurring problems.
  
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• Bachelor’s degree in engineering or a closely related technical discipline; an advanced degree is a plus.
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• At least 15 years of progressive experience in medical-device engineering or product development, including substantial experience with drug-device combination products and injectable delivery systems.
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• Demonstrated people-management experience, including technical mentoring, workload planning, resource allocation, and performance management.
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• Success leading complex development, testing, verification, validation, or investigation programs within regulated environments.
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• Strong working knowledge of design controls, design history files, risk management, statistical analysis, root-cause investigation, and applicable device and combination-product standards.
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• Broad understanding of product design, materials, manufacturing processes, laboratory methods, test equipment, and failure mechanisms.
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• Ability to communicate technical findings and recommendations effectively with clients, engineers, executives, Quality, commercial teams, and external partners.
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• Technical depth in a relevant engineering discipline and sound judgment when evaluating evidence, challenging assumptions, and making decisions.
  
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• Permanent Role
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• Start ASAP
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• 175-200k with bonus
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• Onsite 4 days a week in Northbrook, IL
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• Benefits included: Medical, Dental, Vision, 401k
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