Senior R&D Engineer, Test Development

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 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.

* Conforms with Coloplast Code of Conduct and all local Compliance Standards

* Conforms with Coloplast Q/EHS Policy

* Other duties as assigned

* Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Med Tech Code of Conduct, and company policies.

* Other duties as assigned

Basic 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

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

At Coloplast, we believe in recognizing and rewarding the contributions of our employees. Our total rewards package is designed to support your well-being, foster your professional growth, and ensure a healthy work-life balance. Here is some of what you can expect:

* Health and Wellness:
Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus, access to company sponsored wellness programs and mental health resources, paid leave of absence for qualifying events and generous paid parental leave for both birthing and non-birthing parents.

* Financial Security: A competitive 401(k) plan with company match that vest immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.

* Work-Life Balance:
Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.

* Professional Development:
Opportunities for continuous learning and career advancement through training…