Senior Manufacturing Engineer

Medical Murray • Lake Zurich, IL

6d

About The Position

We are seeking a Senior Manufacturing Engineer who is energized by solving complex manufacturing challenges and leading continuous improvement in a regulated environment. This role blends hands-on production support, process optimization, and customer-facing engineering, offering meaningful influence across product lifecycles—from transfer to sustained production.

You’ll play a key role in ensuring our manufacturing processes deliver products that meet customer expectations for quality, performance, and timeliness, while also mentoring engineers and partnering closely with cross-functional teams.

Requirements

• A strong foundation in manufacturing and process engineering with a passion for continuous improvement.
• 7+ years of experience in sustaining and process engineering; contract manufacturing experience preferred.
• Experience working in regulated environments; ISO, cGMP, and ISO 13485 experience strongly preferred.
• Bachelor’s degree in Industrial Engineering, Mechanical Engineering, or a related discipline (or equivalent experience).
• Proficiency in MS Office and CAD software such as SolidWorks (or equivalent).
• Experience with statistical tools, including DOE and Minitab.
• Strong problem-solving, decision-making, and analytical skills.
• Excellent written and verbal communication skills, with the ability to work effectively across teams and with customers.
• High energy, attention to detail, and a sense of urgency to deliver results.

Nice To Haves

• Six Sigma certification or demonstrated application of statistical and Lean methodologies (preferred).

Responsibilities

• Drive manufacturing excellence by enhancing production processes, equipment, tooling, and layouts.
• Lead the transfer of products into production following design transfer reviews.
• Develop robust manufacturing processes to meet throughput, yield, and cost targets.
• Apply Lean Manufacturing tools such as Value Stream Mapping, 5S, and continuous improvement methodologies to optimize workflows.
• Lead and support changes to existing product lines to improve quality, efficiency, and cost.
• Evaluate and justify capital investments by performing ROI analyses for new equipment and process improvements.
• Select, specify, and implement new manufacturing equipment; develop preventive maintenance procedures as needed.
• Coordinate the design and deployment of custom fixtures, devices, and manufacturing solutions to meet customer and regulatory requirements.
• Manage and execute process validations in accordance with Master Validation Plans, including IQ, OQ, PQ, Gauge R&R, and software validation.
• Analyze production data, lead capability studies, and support data-driven decision making.
• Partner with production teams to ensure smooth handoff of processes, documentation, and training.
• Train assemblers on new or revised assembly procedures to ensure consistent execution.
• Support equipment maintenance and troubleshooting; manage escalations and support equipment re-entry into production.
• Identify and address safety risks related to equipment and processes through procedural updates and equipment improvements.
• Collaborate with Customer Service to communicate product status, risks, and resolutions to customers.
• Participate in project quotations and support cost and feasibility assessments.
• Support annual risk assessments and manage Device Master Record (DMR) updates.
• Mentor engineers and provide technical leadership while overseeing technicians as appropriate.

Benefits

• We offer a competitive compensation and benefits package, including medical (BCBS) and dental coverage, company-paid vision and life insurance, short- and long-term disability, HSA-eligible plans, a 401(k) Safe Harbor retirement plan, 18 days of PTO, TeleDoc access, identity protection, tuition reimbursement, voluntary life insurance, and paid time off for community volunteering.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level