Contract Manufacturing Engineer

Actalent
Kalamazoo, MI
Job Title: Contract Manufacturing EngineerJob Description The Contract Manufacturing Engineer will play a vital role in ensuring efficient and high-quality production processes. This position involves equipment qualification, process validations, and the setup and documentation of manufacturing processes. You will support three main production lines, helping them become operational for product manufacturing. The work will be evenly split between hands-on activities on the production floor and desk-based documentation tasks. This role is crucial in developing processes for an advanced wound care product, primarily focusing on mechanical processes. + The position is a 3-month contract but offers the potential for long-term opportunities based on performance and business needs. Responsibilities + Develop, implement, and continuously improve manufacturing equipment, processes, and systems to support efficient and high-quality production. + Ensure all production equipment and processes comply with Quality Management System (QMS) requirements, Standard Operating Procedures (SOPs), and applicable regulatory standards. + Design, implement, and optimize manufacturing systems and equipment for improved efficiency and reliability. + Support the design, testing, and validation of manufacturing systems and sub-systems. + Lead process qualification and production line validation activities. + Monitor process performance, identify areas for improvement, and implement solutions to enhance throughput and reduce waste. + Troubleshoot and resolve process or equipment issues through root cause analysis and corrective actions. + Collaborate with operations to maximize line utilization, material flow, and efficiency. + Support preventive maintenance and calibration activities to ensure equipment reliability and uptime. + Prepare clear and accurate technical documentation, reports, and work instructions. + Manage multiple open-ended projects requiring creative and analytical problem-solving skills. + Promote a culture of quality, continuous improvement, and professional integrity. Essential Skills + Bachelor's Degree in Engineering. + Experience in equipment qualification and process validation. + Experience in setting up new processes and Process Capability (Cpk). + Proficiency in engineering documentation, including Design of Experiments and SOP/work instructions. + Experience working within a structured QMS (ISO) or GMP or cGMP environment. + Minimum of 5+ years of relevant experience. Additional Skills & Qualifications + Experience with PFMEA. + Launch experience. Work Environment Hours: + 45 hours a week + Typical hours from 7:30/8am to 4:30/5pm. The team will include the Lead Program Manager, Director of Engineering, and a couple of Quality Engineers. The company is a West Michigan-based medical device contract manufacturer with over 25 years of experience, offering assembly, kitting, converting packaging, and sterilization management services. Job Type & Location This is a Contract position based out of Kalamazoo, MI. Pay and Benefits The pay range for this position is $40.00 - $45.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Kalamazoo,MI. Application Deadline This position is anticipated to close on Nov 28, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.
Posted 2025-11-22

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