What are the responsibilities and job description for the Supplier Engineer position at Medical Engineering Consultants (MEC)?
Job 2668 - Supplier Engineer - Contract located near Minneapolis, Minnesota
Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.
MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).
MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.
Onsite
About The Role
As a Supplier Engineer, you'll be the bridge between Our Client's Cardiac Diagnostics CDx cutting-edge design leading the integration of new and existing technologies into CDxs 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 CDxs 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 CDx collaboration across disciplines is key to our client's success.
Responsibilities Include
AAP/EEO DFWP
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.
MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).
MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.
Onsite
About The Role
As a Supplier Engineer, you'll be the bridge between Our Client's Cardiac Diagnostics CDx cutting-edge design leading the integration of new and existing technologies into CDxs 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 CDxs 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 CDx collaboration across disciplines is key to our client's success.
Responsibilities 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 CDxs development and manufacturing processes.
- Leads project teams working closely with Project Management to coordinate with R&D, Design Assurance, Manufacturing Engineering, Operations and Quality 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 CDx
- 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
- Bachelor's degree in engineering or related discipline
- Minimum of 8 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%, approx. 5-10 trip per yr. possible destinations include EU countries, China and within the US
- Design assurance experience with 10 years working in Medical Device development
- Experience working with suppliers and familiar with the application of design controls and supplier controls as per 21CFR820 and MDR
- Auditor of quality systems experience ISO 13485 or similar
- Self-driven and results oriented with strong data analytics and critical thinking skills
- Experience managing projects and working with cross-functional teams to drive deliverables
- Organized and detail-oriented with ability to prioritize and manage multiple projects
- Strong interpersonal and communication skills with ability to develop internal and external relationships
- Sponsorship is not available for this position
AAP/EEO DFWP
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.