Description

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 Product Development Engineer I supports the design, development, testing, and sustaining engineering of medical devices and accessories within a highly regulated environment. This role contributes to concept feasibility, design and process development, verification and validation testing, data analysis, technical reporting, and design transfer to manufacturing. The Product Development Engineer I works cross-functionally to help ensure that product development activities are conducted to fulfill user needs, regulatory requirements, quality standards, and business objectives. The role also provides technical support to Manufacturing, Quality, Regulatory, Marketing, and other internal teams.
Key Responsibilities:

• Support design and development activities by assisting with concept development, feasibility evaluations, and prototype builds.
• Draft user needs, design inputs, and product specifications in collaboration with engineering, quality, manufacturing, regulatory, marketing, and other internal teams.
• Develop and revise specifications for raw materials, device components, accessories, packaging, and manufacturing process requirements, including equipment & tooling.
• Develop and execute verification and validation test protocols, analyze results, and prepare technical reports in accordance with internal procedures, industry standards, and regulatory requirements.
• Coordinate design and testing activities with external vendors, including sample preparation, progress updates, and ensuring completion of all deliverables.
• Generate and maintain design control documentation, including specifications, requirements, traceability matrices, procedures, test protocols/reports, risk documentation, and engineering notebooks.
• Support sustaining engineering including change orders, procedure revisions, labeling updates, and analyzing complaints.
• Collaborate with manufacturing and quality teams in process verification/validation, equipment qualification, and updates to inspection/release criteria.
• Provide technical support across all functional areas as needed.
• Holding 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.
• Perform other duties and tasks as assigned.

Education and Experience (Knowledge, Skills & Abilities)

• Bachelor's degree in Biomedical, Mechanical, Electrical, or Materials Engineering (a related technical discipline may be considered).
• 0-3 years of engineering experience ideally within research/product development of medical devices.
• Familiarity with CAD tools (SolidWorks).
• General knowledge of m aterials, components, test methods, manufacturing processes , sterilization and other technologies common to m edical devices.
• Knowledge of medical device regulations a plus.
• Strong problem solving, experimental design, and analytical skills.
• Good written and oral technical communication skills.
• Proven ability to solve problems through design, testing, and analysis.
• Proven ability to manage multiple tasks, work well within a team, and relate to all levels within the company.

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.