Manufacturing Engineer

Bioventus; Memphis (TN); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading medical device company in Memphis is looking for a Manufacturing Engineer responsible for the support and sustainability of existing products. The position involves managing manufacturing activities, collaborating on new product integration, and ensuring compliance with regulatory standards. Ideal candidates should have a Bachelor’s degree in Engineering and knowledge of Lean principles, with excellent communication skills. This role offers a chance to make impactful contributions in a dynamic team environment.

Qualifications

• Bachelor’s degree in Engineering needed, preferably Mechanical Engineering.
• Knowledge of regulatory requirements for surgical products is essential.
• Clean room manufacturing experience is preferred.
• Green Belt certification in Lean concepts would be an asset.

Responsibilities

• Manage manufacturing activities and technical operations.
• Collaborate on new product development integration.
• Maintain technical product specifications and documents.
• Develop standard operating procedures (SOPs) for best practices.

Skills

Lean principles

Root Cause Analysis

Excellent communication skills

Education

Bachelor's degree in Engineering (preferably Mechanical Engineering)

Tools

MS Office products

Statistical software for data analysis

Solid modeling (CAD/CAM) software

Job description

Overview

Are you ready to work for a more active world? At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.

Main Purpose of the Role: The Manufacturing Engineer is responsible for support and sustaining of existing products. The position is also responsible for delivering basic technical services of products including: installation qualification, upgrades, troubleshooting, repair and preventative maintenance. The responsibilities also include reviewing system performance to minimize equipment downtime and to ensure maximum overall customer satisfaction.

Responsibilities

• Participate in managing manufacturing activities and technical operations functions.
• Collaborate with new product development teams to ensure successful integration of new products into manufacturing.
• Visit external manufacturing sites as needed to provide technical and validation support and training to contract manufacturing organizations along with more senior personnel.
• Create and maintain technical product specifications, standard work, drawings, bill of materials, batch records, procedures, and Global Unique Device Identification Database (GUDID).
• Participate in development, troubleshooting, and manufacturing process improvements with external vendors and assist in the preparation of design controls and design transfer.
• Knowledge of Lean principles, to identify and implement processes to reduce waste and improve manufacturing yield and throughput.
• Develop, manage, and perform all process validation/verification and equipment qualification activities, including writing protocols, analyzing data, investigating deviations, non-conformances, corrective and preventative actions, and writing reports.
• Develop standard operations procedures (SOPs) to ensure best practices are consistently followed across the organization.
• Identify opportunities and resolve process/service issues; gather, analyze and interpret data to determine root cause or errors/nonconformances and implement appropriate corrective actions.
• Measure assigned performance goals for manufacturing operations. Understands internal business processes and supports cross-functional teams in development of new and improved processes.
• Hold oneself and others accountable to conduct business in a manner compliant with Bioventus’ Code of Compliance and Ethics, policies and procedures and internal controls applicable to their role.
• Collaborates with Audit & Risk Management function to identify business risks, and develop and implement preventive strategies for functional area.
• Other duties as assigned.

Education And Experience (Knowledge, Skills & Abilities)

• Bachelor or higher degree in Engineering (preferably Mechanical Engineering).
• Knowledge of applicable state, federal, and international regulatory requirements (i.e. ISO 13485, FDA 21 CFR 820, etc.) for surgical products (i.e. requirements for current good manufacturing practice (CGMPs) for medical devices and biologics.
• Clean room manufacturing experience is preferred.
• Basic Experience in mechanical design of tools, fixtures, and gauges.
• Basic Experience in implementing design to reduce manufacturing costs.
• Knowledge and Experience in Lean concepts, including Root Cause Analysis and DMAIC thinking. Green Belt certification preferred.
• Sound decision making and innovative thinking.
• Excellent communications skills (written and verbal).
• Experience using MS Office products (Word, Excel, PowerPoint, Visio, Adobe, Outlook).
• Experience using statistical software for data analysis.
• Experience using solid modeling (CAD.CAM) software preferred.
• Experience using document control software.
• Knowledge of SAP or other integrated software application is strongly desired but not required.

Application and Diversity Statement

Are you the top talent we are looking for? Apply now. Hit the “Apply” button to send us your resume and cover letter.

Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms of diversity and take pride in working with top talent from every walk of life. In the spirit of inclusivity, qualified applicants will be considered without regard to age, ethnicity, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion or sexual orientation. All individuals, regardless of personal characteristics, are encouraged to apply.