Senior Manufacturing Engineer (Automation)
Ann Arbor, MI

Company Description
MC3 Cardiopulmonary is dedicated to developing and manufacturing innovative and effective new extracorporeal life support (ECLS) technologies that will be used to treat severe heart and lung failure. We have experienced high growth over the past few years and have a state-of-the-art production facility and have launched several successful products. This growth is expected to continue as we seek to become the ECLS market leader.
Position Description
The Senior Manufacturing Engineer plans, directs installation, validates, and oversees manufacturing processes and equipment in a medical device manufacturing environment. The primary responsibility of this position is to provide the project leadership and technical expertise on custom automation equipment and controls utilized in medical device assembly.
Position Responsibilities

• Develop new and/or improved manufacturing methods utilizing knowledge of product design, fabrication processes, tooling and equipment capabilities, assembly methods and quality requirements
• Assures manufacturing efficiency by analyzing and planning workflow, space requirements and layout of equipment
• Develops shop floor work instructions and trains operators on equipment and methods
• Works directly with equipment/machinery suppliers to develop processes, specifications, capability, and suitability for purpose
• Specifies and purchases equipment and machinery.
• Responsible for the installation of equipment.
• Develops and characterizes new and existing assembly processes.
• Writes and executes IQ, OQ, and PQ validations. Partners with Quality Control department on validation strategy.
• Coordinates drafting, approval and ECO release of MWI’s, drawings, procedures, protocols and reports.
• Integral member of product design teams at early stage product development to assure design for manufacturability
• Provides manufacturing decision-making information by assessing labor and material costs, efficiency, capacity, scrap, etc.
• Assists in mentoring and enhancing skill sets of interns and less experienced engineering staff.
• Assists in transfer or sub-contracting of processes to third parties.
• Experienced in designing efficient work flow to meet production and quality requirements using LEAN manufacturing techniques.
• Stays current on applicable safety and environmental codes and regulations to assure compliance on manufacturing equipment and processes

Required Qualifications

• BS degree in Mechanical/Electromechanical Engineering or equivalent engineering degree, or equivalent combination of education and experience.
• Proficient (7+ years) in Automation Engineering involving the electromechanical design, simulation, programming, and fabrication of automated machinery.
• Advanced knowledge of robotics, control systems, instrumentation and the automated control of dynamic processes.
• Experience in selection and/or design of manufacturing equipment, tools and fixtures
• Experience in designing efficient workflow to meet production and quality requirements
• Ability to work effectively with teams and individuals, including assembly personnel
• Skilled in creating/reading technical drawings and specifications
• Excellent technical problem-solving skills
• Excellent written and oral communication skills

Desired Qualifications

• Experience in the disposable medical device industry, or equivalent technical industry.
• Experience writing and executing Master Validation Plans, Process Risk Assessment (PFMEA), Test Method Validations, and Process IQ/OQ/PQ validations.
• Experience in Six Sigma and LEAN manufacturing

Download the PDF file for position responsibilities and qualifications
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MC3 Cardiopulmonary
2555 Bishop Circle W.
Dexter, MI 48130

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