Bioventus · 4 hours ago
Manufacturing Engineer II
Bioventus is focused on helping patients resume and enjoy active lives through the development of their people and products. The Manufacturing Engineer II will support and sustain existing products while delivering technical services, optimizing system performance, and ensuring customer satisfaction.
Health CareHealth DiagnosticsMedical Device
Responsibilities
Responsible for managing manufacturing activities and technical operations functions
Serve as technical subject matter expert (SME) for all medical device products
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
Create and maintain technical product specifications, standard work, drawings, bill of materials, batch records, procedures, and Global Unique Device Identification Database (GUDID)
Lead development, troubleshooting, and manufacturing process improvements with external vendors including preparation of design controls and design transfer
Develop product packaging and establishes test requirements per ISO, and ASTM standards
Using Lean principles, identify and implement processes to reduce waste and improve manufacturing yield and throughput
Responsible to serve as SME for designing, assembling, modifying, and supporting custom designed and off-the-shelf processing equipment
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 (SOP’s) 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. Understand internal business processes and lead 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
Qualification
Required
Bachelor or higher degree in Engineering (preferably Mechanical Engineering)
2 or more years' experience
Knowledge of applicable state, federal, and international regulatory requirements (i.e. ISO 13485, FDA 21 CFR 820, etc.) for surgical products
Experience in mechanical design of tools, fixtures, and gauges
Experience in implementing design to reduce manufacturing costs
Experience in Lean concepts, including Root Cause Analysis and DMAIC thinking
Sound decision making and innovative thinking
Excellent communications skills (written and verbal)
Proficient using MS Office products (Word, Excel, PowerPoint, Visio, Adobe, Outlook)
Experience using statistical software for data analysis
Experience using document control software
Knowledge of SAP or other integrated software application is strongly desired but not required
Preferred
Clean room manufacturing experience
Green Belt certification
Experience using solid modeling (CAD.CAM) software
Company
Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely.
H1B Sponsorship
Bioventus has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (5)
2023 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$827MKey Investors
Wells Fargo
2025-07-31Post Ipo Debt· $400M
2022-04-26Post Ipo Debt· $415M
2021-02-10IPO
Leadership Team
Recent News
2025-12-09
Company data provided by crunchbase