Manufacturing Engineer

Job description
Essential Job Duties And Responsibilities
• Manage medium complexity projects, including communication with internal customers, involving designs or processes.
• Provide technical support to the manufacturing product lines.
• Identify and implement process improvements to increase efficiency and reduce costs.
• Design tools & fixtures (electrical/pneumatics/mechanical) to improve production efficiency.
• Ability to use Solidworks or similar software for product and fixture drawings.
• Develop and maintain manufacturing processes, work instructions, forms, BOMs, routers, FMEAs, DMRs, and other documents as required.
• Collaborate with cross-functional teams to ensure products are manufactured to specifications.
• Participate in product design and development activities, including Design for Manufacturability (DFM) reviews.
• Support process validation activities, including writing and/or performing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Develop and maintain equipment and tooling requirements, including purchasing and maintenance schedules.
• Support new product introductions and product transfers to ensure a smooth transition into manufacturing.
• Ensure compliance with all relevant regulatory requirements and industry standards.
• Evaluate quality control processes and make recommendations for improvements.
• Analyze production processes, schedules, methods, and other data. Provide management with reports containing the data and statistics to enable management to better understand future requirements needed for the manufacturing process.
• Review and calculate labor, material, and other production costs along with reviewing schedules and future production requirements to assist management in decision making.
• Analyze and plan workflow, equipment placement, and space requirements to improve manufacturing efficiency.
• Utilize Six Sigma tools to improve efficiency in manufacturing setting.
• Perform and/or coordinate equipment maintenance and repair services to ensure production equipment is operating optimally.

Requirements
• Experience with computer programming (e.g., Python, MATLAB, etc.).
• Experience with industrial automation, specifically that which uses PLCs and robotics.
• Formal Root Cause Analysis (RCA) training.
• Experience with testing of electro-mechanical medical devices.
• Experienced in supply chain, supplier process development/optimization.
• Experience providing product sustaining activities including technical support of products as they move into the latter or mature stages of the product lifecycle.
• Experience with obsolescence management, software and/or hardware release support, regulatory updates, etc.
• Experience with contract manufacturing of medical device products and/or components.
• Knowledge of FDA regulations and interpretation of FDA regulations, guidelines, and policy statements.
• Experience with electronic and/or mechanical assembly.
• Experience with automated assembly equipment.
• Experience with sustaining and process engineering.
• Lean Six Sigma certification.
• Experience in Design for Manufacturing (DFM), Lean Manufacturing, Design of Experiments (DoE), technology/process transfer experience, product/process failure mode and effects analysis (FMEA), and problem-solving methodologies.

Education & Experience Requirements
• Bachelor’s degree in engineering or a related field.
• 3+ years of experience in a medical device manufacturing environment.
• Knowledge of manufacturing processes and equipment.
• Experience with process validation activities and regulatory requirements (e.g., FDA, ISO).
• Excellent problem-solving skills and ability to work independently.
• Strong communication and interpersonal skills.
• Ability to manage multiple projects and priorities simultaneously.
• CAD software experience (e.g., SolidWorks)
• Experience with creation and implementation of new manufacturing processes and documentation.