Director of Engineering

Full-time

GForce Life Sciences

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.
This 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.
Job Duties
Manage and develop an engineering team, setting clear priorities and performance expectations while providing technical coaching, feedback, and resource direction.
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.
Provide senior engineering review and approval of protocols, reports, test procedures, investigation findings, deviations, design inputs, and risk documentation.
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.
Collaborate with Quality and Operations to coordinate equipment qualification, calibration, preventive maintenance, and laboratory readiness.
Serve as a technical resource for clients, helping define project objectives, evaluate development strategies, communicate risks, and resolve challenging engineering questions.
Contribute to business growth through technical project scoping, proposal development, evaluation of new service opportunities, and client relationship support.
Guide structured investigations and continuous improvement efforts to address technical issues, identify root causes, and prevent recurring problems.
Requirements
Bachelor’s degree in engineering or a closely related technical discipline; an advanced degree is a plus.
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.
Demonstrated people-management experience, including technical mentoring, workload planning, resource allocation, and performance management.
Success leading complex development, testing, verification, validation, or investigation programs within regulated environments.
Strong working knowledge of design controls, design history files, risk management, statistical analysis, root-cause investigation, and applicable device and combination-product standards.
Broad understanding of product design, materials, manufacturing processes, laboratory methods, test equipment, and failure mechanisms.
Ability to communicate technical findings and recommendations effectively with clients, engineers, executives, Quality, commercial teams, and external partners.
Technical depth in a relevant engineering discipline and sound judgment when evaluating evidence, challenging assumptions, and making decisions.
Terms & Start
Permanent Role
Start ASAP
175-200k with bonus
Onsite 4 days a week in Northbrook, IL
Benefits included: Medical, Dental, Vision, 401k

Apply

Vacancy posted 19 hours ago

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