Title: Senior Manufacturing Engineer
Location: Lake Zurich
Employment Type: Full-Time
OverviewBuild. Improve. Lead.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.
What You'll Do- 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.
What You'll Bring- 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).
- Six Sigma certification or demonstrated application of statistical and Lean methodologies (preferred).
- 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.
