Product Development Engineer - Medical Device (Finance)

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The Product Development Engineer I is responsible for the full life cycle development of medical devices, which includes design, development, testing, and product maintenance. Designs or supports the design of functional ultrasonic such as handpieces, probes, wrenches, etc., and modifies existing designs to develop or improve products or to improve the quality of products. Supports team efforts in establishing project design specifications, design output, verification and validation activities, and production transfer. Ensures designs meet relevant regulatory requirements including FDA, IEC, and ISO standards, and FDA Design Control. Performs planning, scheduling, report preparation, testing, field evaluation, and management of engineering projects. Provides technical support to Marketing, Regulatory, Manufacturing, Sales, and Product Service departments.Key Responsibilities:

• Provides expertise for all technical aspects of a project, particularly in the design, development, and troubleshooting of handpieces, probes, tips, horns, wrenches, sterile packs, sterilization trays, and accessories
• Plans and schedules engineering projects and tracks progress to ensure the project meets the required timeline
• Participates in developing design specifications and resolving them into input requirements
• Modifies existing designs and builds prototypes for new and existing products. Writes engineering test protocols/procedures for testing devices and performs engineering tests and measurements
• Works with lab equipment such as Data Acquisition systems, thermal field devices, spectrum analyzers, high-magnification video microscopes, multimeters, thermocouples, pressure and vacuum meters, acoustic meters, force gauges, etc.
• Generates engineering reports and other engineering documentation to support new and existing designs
• Works with outside design and contract manufacturing firms, as well as consultants for outsourced projects
• Supports regulatory compliance testing and provides technical solutions to ensure the product meets applicable safety and regulatory guidelines
• Executes necessary testing and provides associated technical documentation to support foreign registrations
• Prepares project timelines, core project documentation, presentations, design reviews, and project management meetings to support development projects
• Provide necessary technical training for Bioventus Surgical Solutions Territory Managers and field support in the O.R. and labs
• Develop technical solutions to production issues and provide process improvements
• Provides technical leadership for the Product Development team during technology transfers by managing activities and providing the necessary training and technical support
• Assures compliance with company Standard Operating Procedures and policies
• Demonstrates strong knowledge and understanding of GMPs and all other applicable standards, including FDA, ISO, and IEC standards and Design Control for medical devices

Education and Experience (Knowledge, Skills & Abilities)

• Bachelor's degree in Engineering with emphasis on Mechanical Engineering
• 5+ years' experience in medical device industry, electromechanical product experience preferred
• Experience in medical device development and product support, FDA Design Control, and applicable regulatory standards
• Experience in development tools including CAD and 2-D or 3-D FEA
• Strong knowledge of mechanical design with emphasis on vibratory resonant systems
• Strong problem-solving and creative skills with the ability to exercise sound judgment and make decisions based on accurate and timely analyses.
• Effective collaboration skills and ability to work effectively with cross-functional teams
• Must be able to analyze and resolve complex issues of a broad scope using independent judgment, as well as prioritize work.
• Strong hands-on capabilities
• Strong organizational skills
• Knowledge of product development process, design control, and change control procedures
• Ability to carry out engineering tests, analyze data, and provide technical solutions
• Ability to write engineering test protocols and reports
• Exhibit excellent written and verbal communication skills with all levels of the company
• High level of integrity and dependability with a strong sense of urgency and results orientation

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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.