Senior Supplier Engineer

Mounds View, MN, US • Posted 17 hours ago • Updated 17 hours ago

Contract W2

On-site

$65 - $70/hr

Talent Software Services, Inc

Fitment

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Job Details

Skills

SUPPLIER ENGINEERING
MEDICAL DEVICE DEVELOPMENT
DESIGN CONTROLS
RISK MANAGEMENT
PROCESS VALIDATION
CAPA
SUPPLIER CONTROLS
21CFR820
AUDITING
ISO 13485

Summary

Senior Supplier Engineer

Job Summary: Talent Software Services is in search of a Senior Supplier Engineer for a contract position in Arden Hills, MN. The opportunity will be for one year with a strong chance for a long-term extension.

Position Summary: As a Senior Supplier Engineer, you'll be the bridge between Cardiac Diagnostics (CDx) cutting-edge design, leading the integration of new and existing technologies into CDx's 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 CDx, 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.

Primary Responsibilities/Accountabilities:

Working with Medical Device OEM, sub-system and component suppliers to identify suppliern 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 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

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:

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 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

If this job is a match for your background, we would be honoured to receive your application!

Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities, including contract, contract to hire, and permanent placement. Let's talk

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: talmn001
Position Id: 26-01914
Posted 17 hours ago

Company Info

About Talent Software Services, Inc

We pride ourselves in making sure that diversity in the workplace is at the forefront of our business. Our Founder, Dave Iacarella, is an Army Veteran who is committed to giving back to fellow Veterans. We are proud of our history of transitioning military Veterans into the workforce with companies that value their service. TALENT helps companies meet their veteran and diversity spend initiatives and requirements. We are committed to supporting veteran and diverse organizations.

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