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Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

The Senior Engineer (Engineer 3) is a leader in Product Development, participating in projects of varying scope and complexity across all franchises, including Neuro Critical Care, Hydrocephalus, Tissue Ablation, Minimally Invasive Access, Electrosurgery, and Lighting, with a focus on Advance Monitoring and Sensing technologies and products, offering unique and significant skills that advance the capabilities in such fields. The Senior Engineer is responsible for bio mechanical aspects of projects, interacting with external design and development partners, participating on cross-functional project teams through all phases of the product development process, and assisting the technical team with planning, executing, documenting, and communicating testing activities.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Primary responsibilities are to:

• Fulfill design control requirements including the creation of detailed bio mechanical specifications and requirements, detailed design files, design verification and validation test plans, risk management, DHF, protocols, and reports in accordance with company procedures, FDA and ISO guidelines.

• Work with development partners and other external vendors to support project plan deliverables.

• Coordinate and participate in the development of biomechanical and electromechanical architectures for medical devices with particular focus on monitoring systems and sensors.

• Coordinate, review and approve mechanical related documentation created by external partners, including product requirements, design drawings, material specifications, verification and validation test protocols and reports.

• Prepare and lead Design Reviews, Technical Reviews, and Peer Reviews.

• Provide support for field-based Sales Team and other Commercial partners.

• Partner with Downstream Marketing, Sales and key external stakeholders to identify unmet clinical/surgical needs; evaluate options; and provide sound engineering solutions.

• Collaborate with internal and external partners to launch and maintain new products, including, operations, service and repair, regulatory and complaints.

• Mentors junior members of the team.

• Attend industry tradeshows, professional education events, and other company-sponsored events to provide product training and support to customers as needed.

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• Bachelor’s Degree in engineering is required, with preference for Mechanical, Biomechanical or Biomedical Engineering.

• Advanced Degree (MS) in Mechanical Engineering or equivalent is preferred.

• A minimum of 5 years of product development experience (or combination of education and work experience) in a highly regulated product development environment, operating within Design Control procedures, preferably from within the medical device industry.

• Experience in the development of sensors, electromechanical devices, and implantable products.

• Experience in medical device product development is preferred, with emphasis monitoring devices and sensing technologies.

• Knowledge of medical device product development in a regulated environment (e.g., FDA, ISO).

• Demonstrated understanding of various types of manufacturing, mechanisms, materials, proper tolerancing, drafting standards, and GD&T is required.

• Experience using laboratory instruments.

• Black Belt certification is desired.

• Demonstrated aptitude for successfully managing multiple projects, of varying complexity, within the specified guidelines, timeframes and budgets.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.

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