A global leader, partner and resource for innovative medical devices and instrumentation. We design develop and manufacture unsurpassed quality products in the cardiac surgical space.

1      Duties and responsibilities

Process Optimization & Improvement:

• Analyze existing production processes and workflows to identify areas for improvement in efficiency, cost-effectiveness, and quality.
• Design, develop, and implement new and existing manufacturing processes, tooling, fixtures, and equipment for new and existing medical devices.
• Conduct root cause analysis for production issues (e.g., non-conformances, CAPAs) and implement effective corrective and preventive actions.
•  Develop and execute process validation protocols (IQ, OQ, PQ) for manufacturing equipment and processes.
• Maintain the design files and design controls of products currently on the market.

Manufacturing Support & Troubleshooting:

• Provide technical support to production operators and technicians, resolving day-to-day manufacturing challenges.
• Troubleshoot equipment malfunctions and process deviations, working with maintenance and other engineering teams as needed.
• Ensure all production processes comply with safety and environmental regulations.

New Product Introduction (NPI) and Sustaining Engineering:

• Collaborate with R&D Engineering to ensure the manufacturability of new products, providing input on design, materials, and assembly methods.
• Coordinate and manage the manufacturing launch of new/revised products, including establishing goals, training production teams, and evaluating results.
• Develop and qualify supply chains and packaging methods for new products.
• Support Post Market, complaint, supply chain and market proposed design changes.
• Ensure design files are kept current and the latest state of the art.

Documentation & Compliance:

• Generate and maintain comprehensive engineering documentation, including specifications, risk analyses, drawings, reports, protocols, and revisions.
• Prepare and update manufacturing process instructions, standard operating procedures (SOPs), and safe working procedures.
• Ensure all manufacturing activities adhere to Good Manufacturing Practices (GMP), ISO 13485, and FDA regulations (e.g., 21 CFR Part 820).
• Support internal and external audits.

Collaboration & Communication:

• Work cross-functionally with Quality, Supply Chain, R&D, and other departments to ensure seamless product development and production.
• Participate in brainstorming sessions and cross-departmental meetings to foster collaboration and cohesion.
• Mentor and train junior production staff as needed.
• Act as a liaison with third party suppliers to ensure seamless communication and product delivery

2      Qualifications

Education

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Industrial Engineering, or a related engineering field.

Experiences

• 4+ years of experience in production, manufacturing, or sustaining engineering role within the medical device industry.
• Strong understanding of medical device manufacturing processes, design controls, and regulatory requirements (FDA, ISO 13485, GMP).
• Proven experience with process validation (IQ, OQ, PQ).
• Proficiency in CAD software (e.g., SolidWorks, AutoCAD, Creo).
• Experience with ERP/MES systems and production scheduling concepts.

 Skills:

• Demonstrated ability to apply problem-solving methodologies (e.g., Root Cause Analysis, FMEA) and statistical analysis for process improvement.
• Excellent written and verbal communication skills, with the ability to present complex information clearly and concisely. 
• Strong analytical, organizational, and critical thinking skills.
• Ability to work independently with minimal supervision and manage multiple projects in a fast-paced, constantly changing environment.
• Detail-oriented with a strong commitment to quality and patient safety.