Technical Fellow

2 months ago

Minneapolis, Minnesota, United States Coloplast Full time


Technical Fellow

Location:

Minneapolis, MN, US



Job Family:

Research & Development

Country/Region:

United States

Highly experienced Engineer with large breadth of knowledge relating to functions and tasks required to develop medical devices. Has broad knowledge across the areas of discipline under the individuals responsibility that include early concept development and the first principles understanding of the product function and design. This role also has the responsibility of understanding the technical aspects of the product in its entirety. This role must champion ideas, make difficult decisions, and provide guidance to others so that they can develop a product that meets the design intent. As a Technical Fellow, this position plays in large part a mentoring role to the rest of the technical organization as it relates to the overall product features, requirements, and issue resolution



Major Areas of Accountability:

  • Design and develop new concepts and products for their appropriate application to interventional urology products
  • Perform original and iterative design of devices
  • Provide technical guidance and support to other engineers based on overall project objectives plans with the development of products in compliance with design controls and processes
  • Work highly independently in alignment with business objectives for current and future generations of implantable products
  • Generate new intellectual property in accordance with departmental strategic objectives.
  • Create, obtain and maintain all necessary documentation throughout the development cycle for assigned projects by various means of recording.
  • Assure risk mitigation through robust design of implantable devices
  • Develop proper verification tests and validation of such.
  • Consult and advise on the applicability and acquisition of inorganic opportunities for required technologies or products
  • Conduct as required pre-clinical research as well as engagement of industry experts in academia and medical practice to inform design concept requirements and selection.
  • If this position is assigned any responsibilities associated with our hazardous waste handling, then refer to the document Hazardous Waste Job Responsibilities for detailed duties.
  • Conform with Coloplast Code of Conduct and all local Compliance Standards
  • Conform with Coloplast Q/EHS Policy
  • Other duties as assigned


Essential Qualifications:

  • Bachelor's Degree in Electrical Engineering or Bio-Medical with a focus on Electrical Engineering; Master's or PhD in stated disciplines preferred
  • 20+ years related experience and/or training; or equivalent combination of education and experience - Class III medical device experience preferred
  • Understanding of advanced engineering concepts and principles.
  • Direct experience in electrical design and testing
  • Full and robust skillset related to electrical testing and evaluation lab equipment
  • Able to develop test protocols and synthesize data to write test reports based on observed data, relevant test standards and general engineering knowledge.
  • Good understanding of statistical analysis (e.g. normality, two-sample t-test, tolerance limit calculation, etc.)
  • Familiarity with FDA, ISO and EN Standards as they apply to medical devices.
  • Experience with failure mode analysis (FMEA, Fault Tree Analysis), hazard analysis and other risk management procedures.
  • Experience with design control process and procedures, including customer requirement generation, design inputs and outputs, and verification and validation
  • Solid understanding of Quality Management Systems and standard operating procedures
  • Ability to travel up to 10%


Required Knowledge, Skills and Abilities:

  • Ability to work independently or as a technical lead
  • 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 or scientists).
  • Innovative with respect to developing product concepts and test methods.
  • Pro-active; high-performance and results orientation
  • 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 worlds 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.

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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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