Bioventus
Sr Manager, Ops Engineering
– Bioventus
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.
Key Responsibilities
Provide leadership, development, and performance management for the Manufacturing Engineering and sustaining engineering teams.
Develop and execute operations engineering strategy aligned with operational performance goals, product lifecycle objectives, and organizational growth needs.
Partner cross-functionally with Quality, Supply Chain, Planning, R&D, and Service to prioritize engineering resources and ensure alignment on operational priorities.
Lead engineering support for daily performance execution, including troubleshooting, root cause analysis, CAPA, and structured problem-solving.
Drive Lean, Six Sigma, equipment reliability, and operational excellence initiatives to improve throughput, reduce scrap/waste, increase yield, and improve cost efficiency.
Oversee equipment and process validation (IQ/OQ/PQ) and engineering change control to ensure compliant and stable manufacturing operations.
Monitor key performance indicators (quality, throughput, equipment uptime, labor efficiency) and proactively develop actions to support performance improvement.
Support internal and external audits as technical subject‑matter expert for manufacturing processes, validation, and controls.
Partner with manufacturing leadership to ensure readiness for capacity expansion, technology integration, and scaling production.
Maintain responsibility for documentation readiness, product and process changes, and operational risk mitigation.
Foster a culture of accountability, ownership, and continuous development within the engineering team.
Holds 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.
Education and Experience (Knowledge, Skills & Abilities)
Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related field required; Master’s degree in Engineering, Operations Management, or related field preferred.
Minimum 10 years of engineering experience in medical device or other regulated manufacturing industries, with at least 5 years in a leadership role.
Proven experience in operations engineering, line support, process optimization, and change management in a regulated environment.
Strong knowledge of FDA QSR, ISO 13485, and related regulatory standards.
Demonstrated success in leading cross‑functional teams and managing engineering staff.
Experience with ERP/MRP systems and engineering change management tools.
Certification in Lean Six Sigma (Green Belt or higher) preferred.
Place in the Organization Reports to: SVP, Operations
Direct Reports: Yes
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.
Seniority Level: Director
Employment Type: Full‑time
Job Function: Management and Manufacturing
Industries: Biotechnology Research, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Bioventus by 2x
#J-18808-Ljbffr
– Bioventus
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.
Key Responsibilities
Provide leadership, development, and performance management for the Manufacturing Engineering and sustaining engineering teams.
Develop and execute operations engineering strategy aligned with operational performance goals, product lifecycle objectives, and organizational growth needs.
Partner cross-functionally with Quality, Supply Chain, Planning, R&D, and Service to prioritize engineering resources and ensure alignment on operational priorities.
Lead engineering support for daily performance execution, including troubleshooting, root cause analysis, CAPA, and structured problem-solving.
Drive Lean, Six Sigma, equipment reliability, and operational excellence initiatives to improve throughput, reduce scrap/waste, increase yield, and improve cost efficiency.
Oversee equipment and process validation (IQ/OQ/PQ) and engineering change control to ensure compliant and stable manufacturing operations.
Monitor key performance indicators (quality, throughput, equipment uptime, labor efficiency) and proactively develop actions to support performance improvement.
Support internal and external audits as technical subject‑matter expert for manufacturing processes, validation, and controls.
Partner with manufacturing leadership to ensure readiness for capacity expansion, technology integration, and scaling production.
Maintain responsibility for documentation readiness, product and process changes, and operational risk mitigation.
Foster a culture of accountability, ownership, and continuous development within the engineering team.
Holds 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.
Education and Experience (Knowledge, Skills & Abilities)
Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related field required; Master’s degree in Engineering, Operations Management, or related field preferred.
Minimum 10 years of engineering experience in medical device or other regulated manufacturing industries, with at least 5 years in a leadership role.
Proven experience in operations engineering, line support, process optimization, and change management in a regulated environment.
Strong knowledge of FDA QSR, ISO 13485, and related regulatory standards.
Demonstrated success in leading cross‑functional teams and managing engineering staff.
Experience with ERP/MRP systems and engineering change management tools.
Certification in Lean Six Sigma (Green Belt or higher) preferred.
Place in the Organization Reports to: SVP, Operations
Direct Reports: Yes
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.
Seniority Level: Director
Employment Type: Full‑time
Job Function: Management and Manufacturing
Industries: Biotechnology Research, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Bioventus by 2x
#J-18808-Ljbffr