Director of Engineering

BioDerm, Inc. • Geneva, IL • 1h ago

This job was posted by https://illinoisjoblink.illinois.gov : For more information, please see: https://illinoisjoblink.illinois.gov/jobs/13438321

As a Manufacturing Engineering Director your responsibilities will include:

Lead and develop cross-functional engineering teams to drive

innovation, continuous improvement, and end-to-end manufacturing of medical devices from concept through production.

Ensure full compliance with FDA 21 CFR Part 820 cGMP, ISO 13485, and

related regulatory requirements across the manufacturing lifecycle, partnering closely with Quality and Regulatory.

Own manufacturing development and validation activities, including

design controls, risk management, testing, and process validation.

Drive operational excellence through lean manufacturing, automation,

and design-for-manufacturability initiatives to improve quality, scalability, cost, and efficiency.

Deliver projects on time and within budget while providing clear

communication to senior leadership, leading post-launch performance monitoring, and mentoring engineering talent.

The Manufacturing Engineering Director position may be right for you if you:

You thrive in leadership roles, guiding cross-functional engineering

teams to deliver innovative, continuously improving medical device manufacturing solutions from concept through production.

You bring deep regulatory and validation experience, confidently

ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and overseeing risk management, design controls, and testing.

You are energized by engineering improvement, driving lean

manufacturing, automation, and design-for-manufacturability to improve scalability, quality, and cost efficiency.

You excel at project leadership, balancing engineering rigor with

business needs while delivering projects on time, on budget, and with clear communication to senior stakeholders.

You take ownership beyond launch, leading post-production

performance monitoring, root cause analysis, and ongoing design and process enhancements.

You are passionate about people and collaboration, mentoring

engineers, fostering a culture of learning and innovation, and partnering closely with Quality and Regulatory teams to ensure alignment.

Have proven successful experience in capital expenditures and

automation investment projects.

.Qualified candidates will have:

Bachelors or masters degree in biomedical engineering, Mechanical

Engineering, Industrial Engineering, or a related field.

5+ years of experience with manufacturing processes, design for

manufacturability (DFM), and cost reduction strategies in the medical device industry.

At least 3 years of experience in the manufacturing of medical

devices and a strong understanding of FDA 21 CFR Part 820 cGMP, ISO 13485, and other applicable standards.

Experience with machine efficiency, down time, preventative

maintenance, calibrations, validation, QMS (Quality Management Systems) and regulatory adherence.

Energized and comfortable to work in 10% administration, 30%

leadership, and 60% hands-on in the plant environment.

Additional travel of 25% for training, vendor management or

leadership meetings is also required.\ \

Candidates must currently possess unrestricted authorization to work in the United States. Work visa sponsorship is not available for this role.

What will set you apart:

Technical, hands-on manufacturing experience expertise, validations,

design control/transfer.

Regulated medical industry experience and sustaining engineering

Experience with plating (not electroplating)

Experience with medical textile, R&D, design control, and qualityengineering.

Physical Requirements:

While performing the duties of this job, the employee is frequently required to sit, stand and walk to communicate and listen effectively. This will require both office and plant environments.

There is potential for a discretionary bonus, with a target of 10% This bonusis based onpersonal & company performance and is not a guaranteed bonus plan.

The Company offers the following benefits for this position, subject to applicable eligibility requirements:

Medical, Rx, Dental, Vision, Flexible Spending & Health Savings Accounts, EAP, Health Advocacy, Financial Planning, Parental Leave, Care.com, Group Life & AD&D, Voluntary Life Insurance, Short Term & Long Term Disability, 401(k) Plan with Company Match, PTO, Holidays & Leaves, Accident Insurance, Critical Illness Insurance, Hospital Indemnity, Pet Insurance, Identity Theft Protection, Long Term Care + Life Insurance.

You can find more on our Careers Website

Similar Jobs

Contract Administrator - Engineering

Illinois Tollway • Downers Grove, IL • 3h ago

IT & Engineering

This job was posted by https://illinoisjoblink.illinois.gov : For more information, please see: https://illinoisjoblink.illinois.gov/jobs/13441211 Position Overview The Illinois Tollway (Tollway) is dedicated to providin...

3h ago

Go to Apply

CNC Programmer

Middleby Packaging Solutions LLC • Elgin, IL • 3h ago

IT & Engineering

Job Type Full-time Description We are looking for a skilled CNC Programmer specifically proficient in Autodesk FeatureCAM to support our machining operations. The primary focus of this role is to develop high-quality pro...

3h ago

Go to Apply

Automotive Technician - Skilled

Elmhurst Acura Kia • Elmhurst, IL • 16h ago

IT & Engineering

The Ed Napleton Automotive Group is looking for our next Automotive Technician-Skilled. This is an exciting opportunity in a growing, fast-paced industry. Located at Napleton's Elmhurst Acura/KIA, the Automotive Technici...

16h ago

Go to Apply

Sr. Data Scientist Specialist (Remote)

US Foods • Bensenville, IL • 1d ago

IT & Engineering

ARE YOU A CURRENT US FOODS EMPLOYEE? PLEASE APPLY DIRECTLY THROUGH OUR INTERNAL WORKDAY CAREER SITE ( https://www.myworkday.com/usfoods/d/task/2998$47185.htmld ) Join Our Community of Food People! The Sr Data Scientist e...

1d ago

Go to Apply

Electrical Engineer I Assets

City of Naperville • Naperville, IL • 1d ago

IT & Engineering

This job was posted by https://illinoisjoblink.illinois.gov : For more information, please see: https://illinoisjoblink.illinois.gov/jobs/13435670 City of Naperville Employment Opportunity Job Title: Electrical Engineer...

1d ago

Go to Apply

[Union] Operating Engineer

Cushman & Wakefield • Franklin Park, IL • 2d ago

IT & Engineering

Job Title [Union] Operating Engineer Job Description Summary Responsible to ensure the efficient operation and maintenance of mechanical, electrical and plumbing equipment and systems for the assigned property(s). Respon...

2d ago

Go to Apply

[Union] Operating Engineer

Cushman & Wakefield • Franklin Park, IL • 2d ago

IT & Engineering

2d ago

Go to Apply

Remote Azure Cloud Architect

Reyes Holdings • Rosemont, IL • 2d ago

IT & Engineering

Position Responsibilities : ? Design and implement technical solutions for business functional requirements using cloud services and data platforms while guiding stakeholders in strategic planning to achieve impactful ou...

2d ago

Go to Apply

Mechanical Engineer II

ATS Automation • Rolling Meadows, IL • 3d ago

IT & Engineering

ATS Company: ATS Corporation Requisition ID: 16982 Location: Rolling Meadows, IL, US, 60008-3833 Date: Apr 23, 2026 Mechanical Engineer II Mechanical Engineer II WHAT'S IN IT FOR YOU Benefits: Compensation: $80,000 - $11...

3d ago

Go to Apply

Senior Mechanical Engineer 1 - Nuclear

Sargent & Lundy • Warrenville, IL • 3d ago

IT & Engineering

Description This role offers a hybrid work arrangement. You'll spend three days a week in the office, giving you the flexibility to work remotely for two days. You will be involved in nuclear power plant systems design,...

3d ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)