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Company

Original Job Post

Integra LifeSciences · 2 days ago

Engineer I

Princeton, NJ

Full-time

Onsite

Mid Level

3+ years exp

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BiotechnologyHealth Care

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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

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Quality System RegulationGMPDesign ControlProcess ValidationValidation FundamentalsStatisticsProcess CapabilityClean RoomsLyophilizationBiomaterialsGeneral ChemistryMaterials ExpertiseProduct FabricationMachiningElectrical EngineeringStatistical Process ToolsMinitabProblem-SolvingSix SigmaLeanMicrosoft OfficeOutlookPowerpointWordExcel

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

Glassdoor

3.0

Integra LifeSciences is an integrated medical device company.

Founded in 1989

Princeton, New Jersey, USA

1,001-5,000 employees

http://www.integralife.com

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)