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

Job Function Summary

The Interventional Urology Senior Electrical Engineer will be responsible for performing device design and testing over a broad range of technologies to provide new or improved products to the medical device market. This will involve substantial laboratory work. This person will also act as support for cross-functional development teams and projects to fulfill business goals of Coloplast for new products and line extensions.

Major Areas of Accountability

• Create requirement specifications, schematics, and design documentation of various electrical systems for implanted medical products

• Support the development of electrical test methods, including LabVIEW programming, wiring, etc.

• Perform testing using electrical equipment, including oscilloscopes and custom test platforms

• Support assembly of electrical circuits, electrical assemblies, in and out of a cleanroom

• Create test plans and protocols

• Conduct bench test evaluation of new product, product design changes and test failures, as required

• Prepare and review design history file deliverables as required to complete projects and support regulatory submissions

• Assists Project Manager and the team in planning project tasks and schedule

• Assists in resource planning, including definition of responsibilities of external contract resources

• Establish a foundation for future platform work involving implanted and external electronics

• 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

• Bachelor's degree in electrical engineering

• 5+ years' experience in the medical industry, active implantables preferred

• Strong understanding of engineering concepts and principles, as well as good documentation practice (GDP)

• Familiarity with design control process and procedures, including customer requirement generation, design inputs and outputs, verification and validation, and usability

• Experience in analog and digital hardware development and test

• Experience with embedded software systems, including proficiency in C/C++, Python, etc.

• Familiarity with FDA, ISO and EN Standards as they apply to medical devices.

• Familiar with electronic design software tools, Altium Designer preferred

• Familiarity with Bluetooth communication systems preferred

• Ability to travel up to 10%

Competencies

• Good written and verbal communication skills with the ability to listen, articulate and advocate

• Strong technical skills in subject matter area of expertise

• Able to direct others in the completion of their tasks (e.g., technicians and drafters)

• Ability to work independently

• Ambitious and results oriented

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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