Senior Manufacturing Engineer/Medical

Manufacturing Engineer Are you a passionate Manufacturing Engineer ready to make a tangible impact in the medical device field? Do you thrive in a collaborative environment where you can drive process improvement and literally get your hands dirty on the production floor ? We're looking for an upbeat, hands‑on, and highly skilled individual to join our Operations team This role is key to designing, developing, and implementing new and improved manufacturing equipment and processes to bring life‑changing medical devices to market efficiently and with the highest quality. You'll be a vital part of our cross‑functional team, assisting in the development, qualification, and launch of new products and updates to existing medical devices.

What You'll Be Doing (The Fun Stuff) This is an active, hands‑on role where you'll be on the floor, working directly with the team and the equipment.

Your responsibilities

will include: Process Improvement & Optimization: Evaluating manufacturing lines/processes and developing a strategy for new equipment and processes to reduce assembly time (seconds/device) . You'll improve efficiency by analyzing workflow, performing time studies , and soliciting observations from operators. Lean Leadership: Actively participating in Lean initiatives to stabilize production lines and reduce the time to transfer to the Plant. Design & Manufacturability: You'll be the link between design and production, participating in Design for Assembly (DFA) / Design for Manufacturing (DFM) activities to verify the manufacturability of Product Designs.

Risk & Quality Assurance: Taking an active role in PFMEA, DFMEA, Process Mapping, and Critical to Quality (CTQ) reviews assuring specifications are well defined and documented. You will work in compliance with Laborie QMS, ISO13485 , and other applicable standards. Documentation & Planning: Creating and reviewing essential documents like process flow charts , assembly/production tooling strategies , assembly/production line layouts , balance tables (P4), assembly/production capacity analysis , and EHS project plans. You will also create process documentation including Work Instructions, Control Plans , and job safety analysis sheets.

Validation & Qualification: You will manage, execute, document, and support line validation / qualification activities including IQ, OQ, MSA, and PQ . Collaboration & Change Management: Coordinating with cross‑functional teams to ensure an efficient design transfer process, training and guiding others to implement new product designs and updates. You will also facilitate implementation into production meetings for engineering changes. What You’ll Bring to the Team Experience & Education: Senior Engineer or Engineer II: 5‑8+ years’ experience as a Manufacturing/Production Engineer, preferably in Medical Devices with a bachelor’s degree, or 3‑6+ years’ experience with a Master’s degree. (helpful) A Bachelor’s degree in Mechanical/Electrical/Manufacturing Engineering is preferred.

Lean Manufacturing expertise with knowledge of methods and procedures is a must. Strong knowledge of DFM/DFA .

Experience

with ERP systems, preferably SAP . Proficiency in SolidWorks and MS Office . Strong knowledge of CAD software , electromechanical design, and other engineering tools.

Experience

working in compliance with ISO 13485 and/or ISO 9000 standards. Project management skills and the ability to work to tight deadlines. Seniority Level Mid‑Senior level Employment Type Full‑time Job Function Manufacturing and Engineering Medical Equipment Manufacturing Benefits Medical insurance Vision insurance 401(k) #J-18808-Ljbffr