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Marietta

    Sr. Manufacturing Engineer - Marietta, United States - MiMedx

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    Description
    At MIMEDX, our purpose starts with helping humans heal.

    We are driven by discovering and developing regenerative biologics utilizing human placental tissue to provide breakthrough therapies addressing the unmet medical needs for patients across multiple areas of healthcare.

    Possessing a strong portfolio of industry leading advanced wound care & surgical products, we are committed to making a transformative impact on the lives of patients we serve globally.

    We are excited to add aSr. Manufacturing Engineerto our growing Operations team This role will pay between$104,000 - $127,000based on experience and educational credentials. This is a full-time onsite position working in our Marietta, GA headquarters each week.


    POSITION SUMMARY:


    We are seeking a highly skilled and experienced Senior Manufacturing Engineer to join our team in an FDA regulated environment.

    As a Senior Manufacturing Engineer, you will play a key role in driving process improvements, ensuring compliance with FDA regulations, and optimizing manufacturing operations to support the production of high-quality medical devices or pharmaceutical products


    ESSENTIAL DUTIES AND RESPONSIBILITIES:

    Process Optimization:
    Lead efforts to optimize manufacturing processes to improve efficiency, reduce costs, and enhance product quality while ensuring compliance with FDA regulations and industry standards

    Continuous Improvement:
    Implement and champion Lean Six Sigma principles and methodologies to identify and eliminate waste, streamline workflows, and drive continuous improvement initiatives throughout the manufacturing process

    Validation and Qualification:
    Oversee the validation and qualification of manufacturing equipment, processes, and facilities in compliance with FDA regulations, including IQ/OQ/PQ protocols and validation master plans

    Root Cause Analysis:
    Utilize root cause analysis techniques to investigate and resolve manufacturing deviations, non-conformances, and quality issues, implementing corrective and preventive actions (CAPAs) as needed

    Risk Management:

    Conduct risk assessments (e.g., FMEA) to identify and mitigate potential risks to product quality, patient safety, and regulatory compliance within the manufacturing process.


    Technical Support:
    Provide technical expertise and support to manufacturing operations, troubleshooting complex issues, resolving technical challenges, and ensuring timely resolution of production-related issues

    Change Control:
    Manage the change control process for manufacturing processes, equipment, and documentation, ensuring that changes are properly evaluated, documented, and implemented in accordance with FDA regulations and internal procedures

    Documentation and Compliance:
    Maintain accurate and up-to-date manufacturing documentation, including standard operating procedures (SOPs), work instructions, batch records, and validation documentation, ensuring compliance with FDA regulations and company policies

    Cross-functional Collaboration:
    Collaborate closely with cross-functional teams, including Quality Assurance, Regulatory Affairs, Supply Chain, and R&D, to support product development, regulatory submissions, and manufacturing scale-up activities

    Training and Development:
    Provide training and mentorship to junior engineers and manufacturing personnel on manufacturing processes, quality systems, and FDA regulatory requirements

    Qualifications:
    Bachelor's degree in Engineering (Mechanical, Industrial, Chemical, or related field). Advanced degree preferred.5+ years of experience in manufacturing engineering, preferably in the medical device or pharmaceutical industry.

    Strong knowledge of FDA regulations (e.g., 21 CFR Part 820, 21 CFR Part 211), ISO standards (e.g., ISO 13485, ISO 14971), and other relevant regulatory requirements governing manufacturing operations.

    Proven experience in process optimization, lean manufacturing, and Six Sigma methodologies, with a track record of implementing continuous improvement initiatives and driving measurable results.

    Experience with validation and qualification activities, including protocol and work instruction development, execution, and documentation, in compliance with FDA requirements.


    SKILLS/COMPETENCIES:

    Proficiency in root cause analysis techniques (e.g., fishbone diagrams, 5 Whys) and problem-solving methodologies (e.g., DMAIC) for addressing manufacturing deviations and quality issues.

    Excellent communication skills, both verbal and written, with the ability to effectively communicate technical concepts to diverse audiences and influence cross-functional teams.

    Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

    However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

    41 CFR c)


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