What are the responsibilities and job description for the Manufacturing Manager – Biomedical Devices position at Helios Cardio?
Job Title: Manufacturing Manager – Biomedical Devices
Experience Level: Mid-Level (5 years of relevant experience)
About the Role:
We are seeking an experienced Manufacturing Manager to lead the production operations for our family of acellular tissue matrix biomedical devices. The ideal candidate will have extensive experience in the manufacturing of FDA-regulated Class II or Class III medical devices. This role is based in Natick, Massachusetts, and is pivotal in maintaining the high standards of our manufacturing processes.
Key Responsibilities:
- Leadership and Oversight:
- Manage daily manufacturing operations, ensuring optimal performance, productivity, and alignment with company objectives.
- Lead a production team, fostering a culture of continuous improvement, accountability, and collaboration.
- Production Planning:
- Develop and execute production schedules to meet quality, cost, and delivery objectives.
- Monitor and optimize workflows, resources, and processes to enhance operational efficiency.
- Regulatory Compliance:
- Ensure adherence to FDA QMS and Combination Product regulations, including Good Manufacturing Practices (GMP) and ISO 13485 standards.
- Maintain compliance with regulatory requirements including specific documentation, testing protocols, and validation requirements.
- Prepare for and participate in FDA and OSHA audits, ensuring readiness and adherence to all quality and safety standards.
- Quality:
- Collaborate closely with the Quality team to maintain rigorous quality standards and ensure product consistency.
- Oversee the implementation of corrective and preventive actions (CAPA) to address manufacturing challenges.
- Process Improvement:
- Identify opportunities for process innovation, automation, and cost reduction without compromising quality or compliance.
Qualifications:
- Education:
- Bachelor’s degree in Engineering, Manufacturing, Biomedical Sciences, or a related field.
- Experience:
- Minimum of 5 years of relevant experience in the manufacturing of FDA-regulated 510(k) or PMA medical devices or drugs, with expertise in tissue-based or biomaterial products.
- Proven track record of managing manufacturing teams and leading production operations.
- Experience with acellular tissue matrix production or similar biologically derived medical devices is highly preferred.
- Technical Expertise:
- In-depth knowledge of FDA QMS regulations, GMP, ISO 13485, and requirements for 510(k) or PMA submissions.
- Expertise in process validation, equipment qualification, and production troubleshooting for biomaterial products.
- Skills:
- Strong leadership, communication, and organizational skills.
- Problem-solving mindset with a focus on delivering results.
Why Join Us?
Join a team dedicated to advancing healthcare through innovative technology. The biomedical devices of the Helios Group of companies have positively impacted patients' lives for over two decades, and we are committed to maintaining its legacy of excellence. We offer a collaborative and inclusive work environment, competitive compensation, and opportunities for professional growth.
