Integra LifeSciences · 2 days ago
Engineer I
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BiotechnologyHealth Care
Insider Connection @Integra LifeSciences
Responsibilities
Work as part of a cross-functional team to transfer implantable collagen-based products/processes from R&D to full-scale manufacturing.
Lead efforts to create novel processes for full-scale manufacturing of Integra Regenerative products.
Perform hands-on laboratory work for fabricating, testing, and optimizing processes from R&D to full-scale manufacturing.
Work with vendors/suppliers to develop new equipment and establish raw material specifications.
Generate technical documents/reports and compliance documents.
Ensure all appropriate documentation and specifications are in compliance with Integra's procedures and statutory requirements.
Provide technical input for analysis of process changes and maintain effective cross-functional working relationships.
Train personnel on new manufacturing processes and changes implemented to current operations.
Qualification
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Required
BS/MS in Mechanical Engineering, Pharmaceutical Engineering, Chemical Engineering, Materials Science, or equivalent.
3+ years of experience in medical device or pharmaceutical environment.
Experience with Quality System Regulation (QSR), GMP, Design Control, and Process Validation guidelines applied to the Medical Device industry.
Knowledge of validation fundamentals (IQ/OQ/PQ), statistics and process capability (CpK, sampling methodologies, etc).
Experience in clean rooms, lyophilization or biomaterials are desirable.
General chemistry, processing and materials expertise.
Exceptional problem-solving skills.
Practical product fabrication, machining and/or electrical engineering knowledge a plus.
Use of statistical process tools highly desirable, Minitab a plus.
Preferred
Use of statistical process tools highly desired: Minitab, Six Sigma, Lean are a plus.
Be fully versed in the use of Microsoft Office software and tools (Outlook, Project, Powerpoint, Word, & Excel) and use of statistical tools.
Company
Integra LifeSciences
Integra LifeSciences is an integrated medical device company.
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
Recent News
2024-05-25
2024-05-07
2024-05-06
Company data provided by crunchbase