Company Summary:

Centese, Inc. is a fast-paced start-up medical device company developing products to improve outcomes for patients undergoing heart and lung surgery. The first product, Thoraguard, is a fully automated chest tube and chest drainage system at the intersection of patient-centric outcome improvement and digital medicine. We are building a team of multidisciplinary experts passionate about positively impacting the lives of others through technological advancement.

SUMMARY OF POSITION:

As a Sustaining Engineer, you will play a critical role in maintaining and improving the performance and cost of our medical devices. Your primary responsibilities will include alternate supplier qualification, manufacturing process improvement, and root causes analysis on quality issues (supplier, internal, and field). This role requires a strong understanding of mechanical engineering, manufacturing, and quality.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Support design changes, alternate supplier qualification, and process improvements to enhance product cost, reliability and manufacturability
• Collaborate with cross-functional teams including Quality, Manufacturing, and R&D to ensure issues are resolved efficiently and effectively
• Lead longer term effort to improve design for manufacturability and design for assembly for disposable kits & control module
• Lead investigations into product non-conformance issues, determining root causes, and developing corrective and preventive actions (CAPA)
• Monitor product performance data to identify trends and proactively address potential issues
• Document and report findings from root cause analysis, ensuring compliance with regulatory standards
• Participate in the review and update of design control documents, including Design History Files (DHF) and Device Master Records (DMR)
• Assist in maintaining and improving the quality management system, ensuring ongoing compliance with FDA and ISO standards
• Provide technical support to the Clinical Specialists team for escalated product issues
• Stay updated on industry trends and emerging technologies that could impact the product lifecycle

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:

• Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, Industrial or related field)
• 3+ years of experience in sustaining engineering, preferably in the medical device industry
• Strong knowledge of non-conformance management and root cause analysis techniques
• Familiarity with FDA regulations, ISO 13485, and other relevant medical device standards
• Excellent problem-solving skills with a data-driven approach
• Strong communication skills, both written and verbal, with the ability to work collaboratively in a fast-paced start-up environment
• Ability to manage multiple projects and prioritize tasks effectively

PREFERRED KNOWLEDGE, SKILLS, AND ABILITIES:

• Experience with injection molding, extrusion, or other plastic manufacturing methods
• Experience with CAPA processes in a regulated industry
• Familiarity with risk management techniques
• Experience with quality management systems (QMS) software
• Understanding of human factors engineering and usability principles

Benefits:

• Health Insurance
• Dental Insurance
• Vision Insurance
• Paid Time Off
• Sick Leave
• Short & Long-Term Disability
• Life Insurance
• 401(k)
• Wellness Program

Contact:

Please send your resume and contact information to careers@centese.com to apply for this position.