Manufacturing Engineer

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.

Pay:

$90,000.00 - $140,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off Tuition reimbursement

Work Location:

In person