Sr Supplier Engineer

Overview

Possible temp to hire for right individual and if budget allows.

Interviews: 1-2 teams.

This person must be able to travel 5-10% globally (possibly Sweden, China, Finland, also local.) Approximately 5-10 trip per yr.

ONSITE - AH.

Business

Job Title:

Senior Supplier Engineer As a Senior Supplier Engineer, you’ll be the bridge between Cardiac Diagnostics cutting-edge design leading the integration of new and existing technologies into global supply chain. Your work will directly impact the reliability, scalability, and speed at which life-changing devices reach patients.

• As the technical lead, you’ll work with R&D, Quality, Operations, and Regulatory team members to integrate OEM and sub-system supplier designs along with supplied components into CDx’s products to ensure compliance, performance, and safety requirements are met. This role has a wide scope of responsibilities ranging from ensuring supplier design assurance, supplier product development integration assurance, and third-party manufacturing assurance.
• You will apply strong engineering fundamentals to analyze supplied designs, assess supplier process capabilities, and drive corrective and preventive actions that enhance quality, reliability, and manufacturability. At, collaboration across disciplines is key to our success. This position follows a hybrid work model, requiring on-site presence with key partners at least three days per week to support design assurance, supplier technical discussions, and cross-functional problem-solving.

Responsibilities will include:

• Working with Medical Device OEM, sub-system and component suppliers to identify supplier specifications with the end goal of successfully integrating supplied designs and components into CDx’s development and manufacturing processes.
• Partnering with R&D, Design Assurance, Manufacturing Engineering, Operations Quality, and
• Project Management to execute supplier control deliverables according to program needs, such as purchased material qualifications, supplier-driven change assessments, supplier design or capability improvement projects, or regulated compliance assessments.
• Generating and reviewing quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.
• Investigating complaints and managing supplier investigations for both design and manufacturing-related issues.
• Participating in supplier audits to assess design and manufacturing compliance to regulatory standards and CDx agreed specification requirements. Audit activities include the evaluation of audit observations and findings, reporting, follow-up, and confirmation of follow-up actions.
• Acting as a technical expert to ensure repeatable and reproducible quality/reliability during the life of the product.
• Investigating and evaluating suppliers of new and existing technologies for use in future products or to improve quality/reliability of current products.
• Participating in risk assessment of supplier capability, supplier designs and supplier supply processes to support planning and execution including service risk mitigation measures to ensure continuity of supply for Coordinating all phases of supplier engineering work including content for projects and communicating emerging issues and recovery plans with site leadership and stakeholders to gain resources and support
• Demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures

Required Qualifications:

• Bachelor’s degree in engineering or related discipline
• Minimum 5 years of technical experience working in Medical Device development processes
• Experience in design controls, risk management, process validation, and CAPA
• Ability to travel 5-10% globally (possibly Sweden, China, Finland, also local.) Approximately 5-10 trip per yr.

Preferred Qualifications
:

• Design assurance experience with 7+ years working in Medical Device development
• Experience working with suppliers and familiar with the application of design controls and supplier
• controls as per 21
  
  CFR
  820 and MDR
• Auditor of quality systems…