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Integra LifeSciences · 1 week ago
Engineer III, Product Development
Mansfield, MA
Full-time
Onsite
Senior Level
5+ years exp
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Responsibilities
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.
Qualification
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Required
Bachelor’s Degree in engineering is required, with preference for Mechanical, Biomechanical or Biomedical Engineering.
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.
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.
Preferred
Advanced Degree (MS) in Mechanical Engineering or equivalent is preferred.
Experience in medical device product development is preferred, with emphasis monitoring devices and sensing technologies.
Black Belt certification is desired.
Company
Integra LifeSciences
Integra LifeSciences is an integrated medical device company.
1,001-5,000 employees
H1B Sponsorship
Integra LifeSciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (3)
2022 (8)
2021 (5)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$350M2018-05-15Post Ipo Equity· $350M
1995-08-25IPO· nasdaq:IART
Leadership Team
Jan De Witte
President and Chief Executive Officer
Lea Knight
Executive Vice President & Chief Financial Officer
Recent News
2024-05-25
2024-05-07
2024-05-06
Company data provided by crunchbase
