Plant Manager Medical Devices

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Our organization is looking for an experienced Plant Manager to lead our ePTFE manufacturing operations. This position owns the entire production lifecycle, ensuring every product meets the highest quality, safety, and performance standards. If you are looking for an opportunity to make an immediate impact in a high-performance, cross-functional environment producing critical materials necessary to save lives, send your resume today!

Plant Manager Benefits

• 100% top-tier employee paid health insurance benefits
• 401(k) with match
• Flexible work environment with work/home balance
• Generous PTO and sick days
• Inclusive and collaborative work environment

Plant Manager Responsibilities

• Lead all plant operations, including production, planning, staffing, training, and equipment reliability and maintenance
• Maintain segregated workflows for medical (cleanroom) and industrial manufacturing
• Ensure compliance with FDA QSR/21 CFR 820, ISO 13485, and ISO 9001 requirements
• Uphold standards and best practices in GMP, CAPA, and document control
• Drive lean initiatives to improve yield, reduce waste, and enhance uptime and cost efficiency
• Manage supply chain interfaces and ensure material traceability, vendor quality, and optimized inventory
• Track and report KPIs (OEE, FPY, complaints, EHS metrics) and lead root-cause investigations and corrective actions
• Oversee quality deliverables: SOPs, validation (IQ/OQ/PQ), and Device History Records for medical products; COAs and raw-material control for industrial lines

Plant Manager Qualifications

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Materials Science, or a related discipline (advanced degree is a PLUS)
• Minimum of 7 – 10 years in polymer processing, ideally with PTFE/ePTFE extrusion, expansion, and sintering experience
• Proven leadership in both medical device and industrial materials manufacturing environments
• Ability to foster a culture of safety, accountability, and continuous improvement in a collaborative, small-team setting
• Demonstrated success operating under dual-quality systems (ISO 13485 & ISO 9001) and FDA QSR/GMP environments
• Strong background in Lean, Six Sigma, and data-driven problem solving
• Exceptional organizational, communication, and cross-functional leadership skills

At Goodwin Recruiting, we are committed to our core values and providing world class customer service. We are committed to helping our clients navigate and comply with the complex and ever-changing labor laws as well as help ensure that in every hiring decision, internally and with our client partners, that all viable candidates are considered, and the most qualified candidate is offered the role. We evaluate the knowledge, skills, and abilities that meet the requirements of the position and aim to open doors and change lives. We value all people, understanding that uniqueness and diversity foster a stronger team that is innovative and brings varying perspectives to the table. We put our money where our mouth is and are proud of our efforts to identify a broad slate of candidates, with many hiring success stories to share.

JOB ID: 167326

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