29 applicants

Company

Original Job Post

Coloplast · 3 days ago

Senior R&D Engineer, Test Development

Minneapolis, MN

Full-time

Onsite

Senior Level

5+ years exp

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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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Documentation PracticeDevice AssemblyPrototypingDrafting SkillsMaterials KnowledgeTechnical WritingStatistical AnalysisFDA StandardsISO StandardsASTM StandardsEN StandardsFailure Mode AnalysisRisk ManagementDesign ControlQuality Management SystemsStandard Operating ProceduresProblem-SolvingInnovative Communication

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