Manufacturing Engineer

Brief Description

Company Summary:

BioLab Sciences is a regenerative health company focused on providing innovative solutions that encourage the body to heal naturally. Our mission is to manufacture reliable and safe products with the highest quality to help optimize body performance through continuous innovation, education, superior customer service, and teamwork. Since its founding, BioLab Sciences has experienced explosive growth and is actively developing new technologies to innovate, improve the customer experience, and expand its market share within the wound management space. We are seeking individuals who are passionate about making a difference in the work they do and will help support our company’s mission.

Reports To: Director of Project Management and Engineering

Job Overview

We are seeking a detail-oriented and proactive Manufacturing Engineer to provide direction and support for existing products including product and process improvements as well as resolving manufacturing issues that occur throughout the product lifecycle. Collaborates with Marketing, R&D, Quality, and Supply Chain to participate in new product launches, supplier audits, and quality improvements. The role will also support the validation efforts for our production systems and assist with the implementation and management of the Preventative Maintenance (PM) system. This role involves overseeing the drafting, approval, and documentation of validation plans, as well as ensuring the PM system is fully implemented, validated, and effectively utilized. You will be responsible for the oversight and continuous updating of software systems, ensuring that work orders are assigned, tracked, and closed according to established KPI’s.

Essential Functions

Validation Support:

• Assist in drafting, reviewing, and approving validation documentation, ensuring compliance with regulatory and internal standards

Preventative Maintenance System

• Oversee the implementation of the PM system, ensuring it is fully operational, validated, and aligned with business needs
• Continuously monitor and maintain the PM system software, ensuring it remains up-to-date, functional, and compliant with applicable standards

Work Order Management

• Ensure all work orders from the PM system are assigned, tracked, and completed within the designated KPI timeframes

Training

• Lead the training efforts for new system users, ensuring understanding and adherence to the new PM system.
• Provide ongoing support and guidance as necessary

Manufacturing Support

• Actively engage with team members on the production floor, fostering collaboration and ensuring that engineering solutions are implemented effectively
• Responsible for leading projects and managing manufacturing activities and technical operations functions
• Collaborates with new product development teams to ensure successful integration of new products into manufacturing
• Leads development, troubleshooting, and manufacturing process improvements with external vendors including preparation of design controls and design transfer.
• Develops product packaging and establishes test requirements per ISO, and ASTM standards.
• Using Lean principles, identify and implement processes to reduce waste and improve manufacturing throughput

Supervision

• Provide supervision and guidance to contractors and technicians when leadership is unavailable, ensuring tasks are completed according to standards

Compliance

• Ensure compliance with Good Manufacturing Practices (GDP), Standard Operating Procedures (SOPS), and Work Instructions (WIs) in all areas of responsibility
• This job description is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the job. Other duties may be assigned.

Qualifications

Education:

Bachelor’s Degree in Engineering, Manufacturing, or related field

Experience

• Minimum of 5 years of experience in a manufacturing engineer role in a regulated industry in the medical device or biotechnology industries
• Knowledgeable of applicable state, federal, and international regulatory requirements (i.e., 21 CFR 1271, ISO 13485, FDA 21 CFR 820, etc.) (i.e., requirements for current good manufacturing practice (CGMP’s) for medical devices and biologics).

Skills & Competencies

• Strong understanding of PM systems, validation processes, and work order management
• Understanding of routings, BOMs and other ERP elements required to run a compliant manufacturing operation. Experience with launching a ERP preferred.
• Familiarity with GDP, SOPS, and WIs in a manufacturing setting
• Ability to communicate effectively across all levels and interact with cross-functional teams
• Excellent problem-solving and troubleshooting skills
• Lean Six Sigma Green Belt Certification is preferred
• Project Management Certification is preferred

Location: On-Site – Mesa, AZ

What We Offer

Looking for a company to work at can be a daunting task, but we believe that we stand out from the rest. Our company offers a positive and inclusive work environment, opportunities for growth and development, and a commitment to work-life balance. Join us and become part of a team that values your contributions and invests in your success.

Total Rewards Package

• Competitive Salaries
• Health, Dental, and Vision Insurance
• Retirement Plans
• Tuition Reimbursement
• Generous Paid Time Off
• Employee Assistance Program
• No premium payments

BioLab Sciences is an Equal Opportunity employer and does not discriminate based on race, ancestry, color, religion, sex, age, marital status, sexual orientation, national origin, medical condition, disability, veteran status, gender identity, or any other basis protected by law.