Manufacturing Engineer

Medical Engineering Consultants (MEC) supports medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement 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 SMEs (Subject Matter Experts). MEC's mission is to inspire positive cultural change from within and always exceed our clients’ expectations.

This is a hybrid role requiring 3 days on-site in San Diego County, California. Applicants must be authorized to work in the U.S. and this position is not eligible for employer-sponsored work authorization now or in the future.

About The Role

At our client site, this Supplier Engineer II will evaluate, select, and apply standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications. Assignments have clear and specified objectives and require the investigation of a limited number of variables. This role will serve as the liaison between Sourcing and other groups in resolving problems encountered in the supply chain.

Responsibilities

• Participate in large-scale projects or sub-workstreams under guidance from senior engineering staff; use all relevant business tools & Core Supplier Engineering procedures including Material Qualification activities and all required Windchill activity.
• Participate in project teams cooperating with cross-functional team members to qualify and improve supplier processes; plan, schedule, conduct, or coordinate detailed phases of the engineering work in a part of a major project.
• Interface with suppliers with support from commodity team members to drive investigation of supplied material issues or supply constraints.
• Execute material investigations to determine and address the root cause for defective components; support material investigations where defects in supplied materials are identified within the supply base.
• Oversee and coordinate supply base Notifications of Change; demonstrate proficiency in using the Supplier Change Impact Assessment process to implement supplier-related changes in the relevant Quality Management System.
• Travel 10-15% globally.

Requirements

• Bachelor's degree in engineering with a minimum of 3 years of supplier and/or manufacturing operations experience.
• 2-4 years of Supplier Engineering experience; medical device experience required.
• Experience in supplier relationship and/or purchased component management.
• Demonstrated engineering fundamentals (LEAN, Six Sigma, DFM, statistical methods, etc.) and problem-solving skills.
• Demonstrated cross-functional teamwork in a technically demanding environment.
• Strong written and verbal communication skills.

Preferred Qualifications

• Bachelor's Degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or equivalent.
• Neuromodulation-specific supplier and/or manufacturing engineering experience.
• Prior experience in the medical device industry or similar highly regulated industry.
• Self-starter with strong problem-solving and critical-thinking skills.
• Effective communication and presentation skills.