Job Description
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 MedTech 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 programs, mentorship, and tuition reimbursement.
Recognition and Rewards:
Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
Community and Culture:
A supportive work environment where everyone feels valued, and has a sense of belonging. Participate in team-building activities, volunteer opportunities, and company-sponsored events. Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.
Competitive Compensation:
The compensation range for this position is $108,191 - $162,287. Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location. Hired candidates may be eligible to receive additional compensation in the form of bonuses and/or incentives. 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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