Regulatory Compliance Engineer

Re:Build Manufacturing • Kalamazoo, MI

3d

About The Position

The Regulatory Compliance Engineer completes tasks directed by Tekna’s quality assurance framework, supporting New Product Development (NPD) and helping ensure product safety, efficacy, reliability, and compliance with applicable regulatory requirements. The role supports Core Leadership on NPD projects, including mentoring other assigned compliance engineers, and works with Project Managers, Design Engineers, Production Engineers, and Procurement Specialists. Responsibilities span risk management, product and process requirements, manufacturing readiness, verification and validation, and transfer of designs into Operations.

Requirements

• Bachelor of Science degree in engineering preferred.
• 1 to 3 years of experience in Regulatory Compliance or Advanced Quality, and/or 5 or more years of experience in new product development preferred.
• Proficiency in statistical analysis and control preferred.
• Ability to read blueprints.
• Computer literacy.
• Problem-solving skills.
• Communication skills.
• Organizational skills.

Nice To Haves

• Bachelor of Science degree in engineering.
• 1 to 3 years of experience in Regulatory Compliance or Advanced Quality, and/or 5 or more years of experience in new product development.
• Proficiency in statistical analysis and control.

Responsibilities

• Support the Core Leadership role on NPD projects; delegate work to and mentor other compliance engineers assigned to those projects.
• Support the Project Manager in creating a Design History File and ensure conformance with the Quality Management System.
• Initiate and maintain project plans that optimize product quality, project schedule, and project/product cost according to the Master Project Plan.
• Conduct research and establish product requirements.
• Lead risk management, coordinate Risk Management Board reviews, and complete the Risk Management report required for product launch.
• Support the Production Engineer, typically an Advanced Manufacturing Engineer (AME), with 6M analysis during production-process development.
• Support the Procurement Specialist with supply chain management and PPAP.
• Support the Design Engineer and Production Engineer with Failure Mode and Effects Analysis (FMECA).
• Oversee design for basic safety requirements and compliance with applicable safety standards.
• Conduct Design for Manufacturing Analysis.
• Support the Production Engineer in completing Process Flow and Layout Diagrams.
• Design and develop verification processes and procedures for incoming, in-process, and final inspection in support of the established production process.
• Support the Production Engineer in completing the Process Verification and Validation Matrix.
• Support the Production Engineer in completing process qualification (installation qualification, operational qualification, and performance qualification) and achieving Cpk/Ppk objectives.
• Support the Design Engineer in setting up and qualifying in-house verification test methods and coordinating third-party certification testing in compliance with applicable standards and regulations.
• Support design transfer from the NPD Design History File to Operations PDM.

What This Job Offers

• Job Type: Full-time