Sr Manager, Ops Engineering

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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.

The Senior Manager, Operations Engineering provides strategic and technical leadership for Manufacturing Engineering and sustaining engineering support across production and service operations. This role leads and develops the engineering organization responsible for manufacturing process optimization, equipment and tooling performance, new product and sustaining engineering support, and continuous improvement activities. The role drives operational stability, regulatory compliance, and process capability within a fast-paced, highly regulated medical device environment and plays a critical part in the long-term growth and maturity of the engineering function.

Key Responsibilities:

• Provide leadership, direction, and performance management to the Manufacturing Engineering team, ensuring alignment with site and corporate objectives.
• Develop and execute the Operations Engineering strategy to support business growth, compliance, and product lifecycle needs.
• Serve as the primary point of contact for sustaining engineering activities across USX operations.
• Oversee the implementation and validation of changes to manufacturing processes, equipment, and tooling to ensure optimal performance and compliance.
• Lead problem-solving efforts for manufacturing and service-related issues, implementing robust corrective and preventive actions.
• Drive Lean, Six Sigma, and other continuous improvement initiatives to increase efficiency, reduce waste, and improve product quality.
• Monitor and analyze manufacturing performance metrics to identify and address trends or issues proactively.
• Ensure cost-effective solutions without compromising product quality, safety, or compliance.
• Ensure all operations engineering activities comply with FDA QSR, ISO 13485, and other applicable regulatory requirements.
• Support internal and external audits as the technical subject matter expert for manufacturing processes.
• 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 with at least 5 years in a leadership role over engineers and technicians.
• Demonstrated leadership of product/process changes, resolution of quality/productivity issues and opportunities, and demonstrated success in implementing improvement projects across quality, cost, safety, and delivery.
• Proven experience in operations engineering, line support, product qualifications, process optimization, and change management in a regulated environment.
• Must have experience in a lean production environment with daily accountability for ensuring production output from an engineering perspective.
• Must have experience working with vendors to produce components and assemblies working from design drawings and documentation.
• Deep experience in solving technical and product/process quality issues
• 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

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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.