Bioventus · 18 hours ago
Sr Quality Engineer
Memphis, TN
Full-time
Onsite
Senior Level
5+ years expBioventus is a company focused on helping patients lead active lives, and they are seeking a Senior Quality Engineer. This role involves providing quality engineering expertise to ensure products meet high quality standards and comply with medical device regulations.
Health CareHealth DiagnosticsMedical Device
Responsibilities
Ensure medical device regulatory requirements (21 CFR 820, EU MDD/MDR, ISO 13485:2016 and IEC 60601 series) related to design control and process/product goals (e.g., process capability, yield, reliability) are met utilizing project planning and execution skills
Identify and manage needs/requirements and assist with the creation and/or modification of product and process specifications
Lead design transfer activities focused in development of gage design, inspection processes, GR&R, capability studies and process validation
Actively participate in Design Review activities of new products and work closely with product design teams to manage quality considerations during all PLM stages of product development
Provide guidance and work to solve significant or chronic process or product problems. Discuss customer concerns or complaints with Marketing and Sales as needed
Generate, analyze, and present reports on quality related Key Performance Indicators (KPIs) such as line yields, final release, supplier performance and customer experiences to internal product improvement teams
Support Quality Systems such as delivery holds, internal and external audits, CAPA and investigations
Update and revise procedures to consistently meet regulatory requirements such as EU MDR, IEC 60601 series, ISO 13485:2016, 21 CFR 820, etc
Analyze and act on process trend data including leading investigations, root cause analysis and assist with corrective actions
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
Other duties as assigned
Qualification
Required
Bachelor's degree in an Engineering discipline or equivalent technical background, with emphasis or experience in electronics, circuits and/or software
Minimum 5 years (with Bachelor's) or 4 years (with Master's) of experience within the medical device industry with a comprehensive understanding of, and ability to interpret regulations and guidelines governing medical devices including ISO 13485 and 21 CFR 820 and EU MDD/MDR
Strong working knowledge of process and product development and validation methodologies (IQ,OQ,PQ)
Experience interacting directly with suppliers, Manufacturing, and Manufacturing support organizations
Understanding and experience in applying quality engineering concepts such as process capability analysis, risk management, PFMEA and DFMEA
Previous Quality Engineering or Product Development experience and GD&T and electronics knowledge/experience is required
Preferred
Masters preferred
Electrical Engineering or related fields preferred
Company
Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely.
1001-5000 employees
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
Mark Singleton
Senior Vice President and Chief Financial Officer
M
Miguel O. Beltran-Delgado
Senior Vice President Operations
Recent News
2025-12-09
Company data provided by crunchbase