Coloplast · 5 days ago
Senior R&D Engineer, Test Development
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Health CareManufacturing
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Responsibilities
Provide technical support for product development in compliance with design controls and project plans
Collaborate with R&D, Manufacturing, and Quality teams to evaluate testability of requirements and develop verification test procedures
Lead the development and maintenance of design verification test procedures, test method validation procedures, and equipment qualifications
Identify testing parameters, equipment, and requirements for new test methods
Analyze test anomalies, create technical documents, and optimize lab resources
Identify upgrades and new equipment for continued lab capability
Support the creation and maintenance of QMS documents
Develop tests using human and animal tissue models
Comply with ethical standards, laws, regulations, and company policies
Perform other duties as assigned
Qualification
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Required
BS in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or equivalent
5+ years related experience and/or training; or equivalent combination of education and experience
Strong understanding of engineering concepts and principles, as well as good documentation practice (GDP)
Experience with device assembly, tolerancing, prototyping, and possess basic drafting skills
Good understanding of materials as they relate to medical devices
Innovative with respect to developing product concepts and test methods
Strong technical writing skills to communicate with development teams and develop test protocols, synthesize data, and test reports
Familiarity with statistical analysis (e.g. two-sample t-test, tolerance limit calculation)
Familiarity with FDA, ISO, ASTM, and EN Standards as they apply to medical devices
Familiarity with failure mode analysis (FMEA, Fault Tree Analysis), hazard analysis and other risk management procedures
Familiarity with design control process and procedures, including customer requirement generation, design inputs and outputs, verification and validation, and usability
Good understanding of Quality Management Systems and standard operating procedures
Able to travel, both domestic and international, as required
Benefits
Health Insurance
Company
Coloplast
Coloplast is a manufacturer of medical devices that offers ostomy, continence, and wound care products.
Funding
Current Stage
Public CompanyTotal Funding
$1.34B2023-08-29Post Ipo Equity· $1.34B
2014-09-26IPO· etr:CBHD
Leadership Team
Recent News
2024-05-13
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