Director of Engineering

GForce Life Sciences; Chicago (IL); On-site; USD 175,000 - 200,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401k

Job summary

GForce Life Sciences is seeking a Director of Engineering for a hands-on leadership role focused on drug-device combination products. You will set technical direction, mentor engineers, and partner with clients from early development through verification, validation, and DHF execution.

You will lead teams across autoinjectors, pen injectors, prefilled syringes, on-body wearables, and related delivery platforms, ensuring robust design controls, risk management, and compliant development in a

Qualifications

• Bachelor’s degree in engineering or closely related field; advanced degree a plus.
• 15+ years of progressive medical-device engineering/product development experience, including drug-device combinations.
• Proven people-management experience: mentoring, workload planning, resource allocation, performance management.
• Experience leading complex development, testing, verification, validation, or investigations in regulated environments.
• Strong knowledge of design controls, design history files, risk management, statistics, root-cause analysis, and device standards.
• Broad understanding of product design, materials, manufacturing processes, lab methods, test equipment, and failure modes.
• Excellent communication of technical findings to clients, engineers, executives, Quality, and partners.

Responsibilities

• Manage and develop an engineering team with clear priorities and performance expectations.
• Oversee programs for medical devices and combination products, including requirements, validation, and DHF support.
• Provide senior engineering review of protocols, reports, and risk documentation.
• Improve laboratory execution with better testing practices, equipment readiness, and documentation.
• Collaborate with Quality and Operations on equipment qualification and calibration.
• Serve as a technical resource for clients, defining project objectives and communicating risks.
• Contribute to business growth through project scoping, proposals, and client relationship support.
• Guide investigations and continuous improvement to root causes and prevention.

Skills

People management

Engineering leadership

Drug-device combos

Design controls

Quality collaboration

Client communication

Education

Bachelor’s degree in engineering

Advanced degree preferred

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.
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