Senior R&D Engineer, Test Development Job Details | Coloplast A/S

The Senior R&D Engineer will be a core member of development teams, and responsible for extracting the early signs of a product requirement and translating that into a test environment. The testing support will start in early concept and will continue through into verification stages of a project. This person will act as technical lead in their role, providing support for interdepartmental development teams and projects to fulfill business goals of Coloplast for new products and line extensions. In addition this role will interact with Coloplast personnel and external physicians.

Major Areas of Accountability:

• Provide technical support for the development of products in compliance with design controls and project plans

• Collaborate with R&D, Manufacturing, and Quality teams to evaluate testability of requirements, and translate those requirements into verification test procedures

• Lead the development and maintenance of documents for design verification test procedures, test method validation procedures, and equipment qualifications

• Identify testing parameters, associated equipment, and requirements to complete the development of new methods

• Obtain and maintain all necessary information and experimental test results related to assigned projects by various means of recording

• Analyze test anomalies and create test summary and report style technical documents

• Optimize the lab space, equipment, and resources to meet objectives

• Identify upgrades and new equipment, and lead the acquisition to ensure continued lab capability for product support

• Support the creation and maintenance of relevant QMS documents

• Development of tests with human and animal tissue models.

• Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.

• Other duties as assigned

Essential Qualifications:

• 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

Knowledge, Skills and Abilities:

• Ability to work independently and to be a technical lead on group projects

• Ability to take verbal instructions and translate them into goals and objectives

• Good written and verbal communication

• Able to direct others in the completion of their tasks (e.g., technicians, lower-level engineers and scientists)

• Pro-active; high-performer and results oriented

• Ability to consistently work, manage and lead with ethical integrity

• Personifies Coloplast Mission, Values and Vision as well as Coloplast Leadership Principals

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16,000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward - we explore, learn and look for new ways of doing things.

Visit us on Coloplast.com.

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Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

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