Senior R&D Engineer, Test Development

The Senior R&D Engineer will be a core member of development teams, responsible for extracting early signs of a product requirement and translating them into a test environment. They will provide testing support from early concept through verification stages, act as a technical lead, and collaborate with interdepartmental teams to fulfill business goals for new products and line extensions. The role also involves interaction with Coloplast personnel and external physicians.

• 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 translate them 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 develop new methods
• Obtain and maintain all necessary information and experimental test results related to assigned projects
• Analyze test anomalies and create test summary and technical report documents
• Optimize lab space, equipment, and resources to meet objectives
• Identify upgrades and new equipment and lead acquisition to ensure continued lab capability for product support
• Support creation and maintenance of relevant QMS documents
• Develop tests with human and animal tissue models
• Conform to Coloplast Code of Conduct and all local compliance standards
• Conform to Coloplast Q/EHS policy
• Other duties as assigned

• 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, and good documentation practice (GDP)
• Experience with device assembly, tolerancing, prototyping, and 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 produce 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

• 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 Principles

• Health and Wellness
  :
  Comprehensive medical, dental, and vision insurance plans; company‑sponsored wellness programs and mental health resources; paid leave of absence for qualifying events; generous paid parental leave for both birthing and non‑birthing parents.
• Financial Security
  :
  Competitive 401(k) plan with company match that vests immediately; financial planning services; corporate discount programs for goods and services.
• Work‑Life Balance
  :
  Generous paid time off, flexible work hours, and flexible work arrangement options.
• Professional Development
  :
  Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
• Recognition and Rewards
  :
  Recognition programs to celebrate…