Director of Mechanical Engineering (Medical Device) in Chicago, IL

Are you an accomplished engineering leader with a passion for medical device innovation? We are seeking a Director of Mechanical Engineering (Medical Device) in Chicago, IL to lead the design, development, and optimization of cutting-edge medical devices. This role is ideal for a hands-on, strategic professional with expertise in mechanical engineering, regulatory compliance, and product lifecycle management within the medical device sector.

As the Director of Mechanical Engineering (Medical Device) in Chicago, IL, you will oversee a team of engineers, drive R&D initiatives, and ensure the successful commercialization of groundbreaking medical technologies. If you have a strong technical background in mechanical systems, experience in FDA-regulated product development, and a track record of leading engineering teams, this opportunity is tailored for you.

About This Role

The Director of Mechanical Engineering (Medical Device) in Chicago, IL plays a critical role in advancing the company’s medical technology portfolio by leading product design, prototyping, and validation efforts. This position requires a leader who can balance technical innovation with regulatory compliance while fostering collaboration between cross-functional teams. You will be responsible for implementing best practices in design control, optimizing manufacturing processes, and ensuring that medical devices meet industry standards and regulatory requirements.

This leadership role demands expertise in mechanical systems, materials science, and design-for-manufacturing principles. The Director of Mechanical Engineering (Medical Device) in Chicago, IL will also play a key role in mentoring engineering teams, engaging with key stakeholders, and contributing to the long-term strategic growth of the company’s medical device division. If you’re ready to drive innovation and engineering excellence in the healthcare technology space, we want to hear from you.

Key Responsibilities – Director of Mechanical Engineering (Medical Device) in Chicago, IL

Lead Mechanical Engineering Strategy & Innovation

Develop and execute engineering strategies to drive product innovation and improve existing medical device designs.
Identify emerging trends, materials, and technologies to enhance product performance and manufacturability.
Ensure engineering solutions align with regulatory, market, and business objectives.

Oversee Product Design & Development

Lead mechanical design efforts for new product development and enhancements to existing medical devices.
Guide the selection of materials, components, and manufacturing processes to optimize performance and cost-effectiveness.
Ensure compliance with ISO, FDA, and other regulatory requirements during product development.

Manage Engineering Teams & Cross-Functional Collaboration

Lead, mentor, and develop a team of mechanical engineers, fostering a culture of technical excellence and innovation.
Collaborate closely with R&D, quality assurance, and regulatory teams to ensure seamless product development.
Facilitate effective communication between engineering, manufacturing, and commercial teams.

Ensure Regulatory Compliance & Quality Standards

Oversee design control processes, risk assessments, and documentation in compliance with FDA, ISO 13485, and GMP regulations.
Work closely with quality teams to implement robust verification and validation procedures.
Ensure all mechanical engineering activities adhere to industry best practices and safety standards.

Optimize Manufacturing & Design-for-Manufacturing (DFM) Principles

Work with manufacturing teams to streamline production processes and improve scalability.
Implement DFM principles to enhance production efficiency and reduce costs.
Identify and resolve mechanical design challenges that impact manufacturability.

Drive Prototyping & Testing Initiatives

Oversee prototype development and testing to ensure functionality, durability, and regulatory compliance.
Collaborate with testing laboratories and external partners for product validation.
Analyze test results to refine and improve product designs.

Lead Cost-Reduction & Performance Optimization Efforts

Identify cost-saving opportunities in design, materials, and production processes.
Drive continuous improvement initiatives to enhance product reliability and efficiency.
Develop engineering solutions that balance cost, performance, and regulatory requirements.

Engage with Key Stakeholders & Executive Leadership

Provide technical leadership and strategic guidance to executive management.
Engage with external partners, suppliers, and industry experts to enhance engineering capabilities.
Represent the company at medical device conferences and engineering forums.

What The Client is Looking For in You

To succeed as the Director of Mechanical Engineering (Medical Device) in Chicago, IL, you must be a results-driven leader with a strong background in medical device engineering and regulatory compliance. The ideal candidate will bring:

Extensive Experience in Medical Device Engineering – A deep understanding of mechanical engineering principles, materials science, and product development specific to the medical device industry. Experience in Class II or Class III medical devices is highly preferred.
Proven Leadership & Team Management Skills – A track record of successfully leading and mentoring engineering teams, fostering innovation, and driving high performance in a cross-functional environment.
Expertise in Regulatory Compliance & Quality Standards – Strong knowledge of FDA regulations, ISO 13485, GMP, and design control principles to ensure full regulatory compliance throughout the product lifecycle.
Strong Problem-Solving & Analytical Abilities – The ability to identify engineering challenges, propose innovative solutions, and optimize product design for manufacturability and performance.
Experience with Product Commercialization – Demonstrated success in taking medical devices from concept to market, including prototyping, testing, and manufacturing scale-up.
Collaboration & Communication Skills – A proactive and collaborative approach to working with R&D, manufacturing, regulatory, and executive leadership teams to drive projects to completion.
Technical Expertise in Design & Manufacturing – Hands-on experience with CAD software, finite element analysis (FEA), rapid prototyping, and design-for-manufacturing (DFM) principles.
Passion for Innovation & Continuous Improvement – A forward-thinking mindset with a focus on advancing medical technologies and improving patient outcomes through engineering excellence.

Why This Opportunity Stands Out

This position offers a rare chance to make a significant impact in the medical device industry while leading cutting-edge engineering initiatives. Here’s why this role is an exceptional opportunity:

Lead Innovation in Medical Device Engineering – Be at the forefront of designing and developing life-changing medical technologies that improve patient care.
Executive-Level Influence – Work closely with top leadership to shape the company’s engineering vision and product development roadmap.
Cross-Functional Collaboration – Engage with R&D, manufacturing, regulatory, and commercial teams to bring innovative medical devices to market.
Competitive Compensation & Benefits – Enjoy a lucrative salary, performance-based incentives, and a comprehensive benefits package tailored for executive leaders.
Opportunity for Market Expansion – Play a key role in launching new medical technologies and expanding product offerings into global markets.
Work with a High-Performing Team – Join a dynamic and collaborative environment where innovation, teamwork, and professional growth are highly valued.
Drive Meaningful Impact in Healthcare – Your work will directly contribute to the development of cutting-edge medical devices that enhance patient outcomes and improve lives.

FAQs About the Role

Q: What industries should I have experience in?
A: Candidates must have experience in the medical device industry, specifically in mechanical engineering, product development, and regulatory compliance.

Q: Is relocation required for this position?
A: The role is based in Chicago, IL. Candidates must be open to relocation or already reside in the area.

Q: What is the reporting structure for this role?
A: The Director of Mechanical Engineering (Medical Device) in Chicago, IL will report directly to the Vice President of Engineering and work closely with the executive leadership team.

Q: What kind of leadership style is expected?
A: We seek a strategic, results-driven, and hands-on leader who can inspire teams, foster innovation, and drive product development success.

Q: What is the expected travel requirement?
A: This role may require occasional domestic and international travel for supplier visits, manufacturing assessments, and industry conferences.

Q: What qualifications and skills are required?
A: Candidates should have a bachelor’s or master’s degree in mechanical engineering or a related field, along with 10+ years of leadership experience in medical device engineering. Strong knowledge of FDA regulations, ISO 13485, and design controls is essential.

Q: How does this role contribute to the company’s overall success?
A: The Director of Mechanical Engineering (Medical Device) in Chicago, IL plays a critical role in leading product development, ensuring regulatory compliance, and optimizing engineering processes to drive business growth and market success.

Q: What is the timeline for hiring and onboarding?
A: The company is actively seeking the right candidate and aims to complete the hiring process within the next 60–90 days. Onboarding will include strategy meetings with leadership, technical training, and alignment on engineering and product development objectives.

What Remuneration Can You Expect from This Job?

As the Director of Mechanical Engineering (Medical Device) in Chicago, IL, you can expect a highly competitive compensation package that reflects your leadership role and technical expertise in medical device engineering. The base salary for this position typically ranges from $180,000 to $230,000 per year, depending on experience, industry knowledge, and past achievements in product development and engineering leadership.

In addition to the base salary, this role offers performance-based bonuses and incentives, aligned with key milestones such as successful product launches, regulatory approvals, and manufacturing efficiency improvements. For top candidates, equity options or stock grants may also be available, providing an opportunity to share in the company’s long-term growth and success.

The benefits package includes comprehensive healthcare coverage (medical, dental, and vision), a 401(k) retirement plan with company matching, paid time off, and professional development opportunities. Additional perks may include relocation assistance, travel allowances, and executive-level training programs.

This role not only offers a lucrative compensation structure but also provides the opportunity to drive impactful innovation in the medical device industry, working alongside a dynamic team dedicated to engineering excellence and patient care advancement.

How to Apply for This Director of Mechanical Engineering (Medical Device) Position in Chicago, IL

If you are a results-driven engineering leader with expertise in medical device development, we invite you to apply for the Director of Mechanical Engineering (Medical Device) in Chicago, IL. This is an excellent opportunity to lead innovative product development efforts, drive regulatory compliance, and contribute to the success of a growing medical device company.

To apply, please submit your resume and a cover letter detailing your experience in mechanical engineering, medical device development, regulatory compliance, and leadership within the healthcare technology sector.

This position offers a rewarding opportunity to lead high-impact engineering initiatives, collaborate with cross-functional teams, and play a pivotal role in the commercialization of cutting-edge medical devices. Apply today to take the next step in your career as a Director of Mechanical Engineering (Medical Device) in Chicago, IL!

For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.

Tags:

Job Category: Director of Mechanical Engineering

Job Type: Full Time

Job Location: Chicago