The Job Responsibilities

  • Serve as the clinical engineering lead on assigned project team with accountability for planning, managing, and executing clinical engineering activities according to the program plan and communicate key clinical engineering project risks/concerns.
  • Contribute to the definition of design inputs as it pertains to user and performance needs/requirements and support implementation teams to ensure the most desired solutions are delivered that meets the needs of the patients and clinicians.
  • Participate in product risk analysis to identify clinical risks, including use related hazards, that may result due to normal use, reasonably foreseeable misuse, or abnormal use in collaboration with the risk manager and other engineering disciplines in accordance with internal processes and standards (ISO 14971).
  • Develop and maintain relationships with clinical experts to gain understanding of clinical needs, product opportunities, and technology direction to translate to product development teams.
  • Responsible for product validation including planning, writing test protocols, managing test sites, gathering clinical data, performing data analysis, identifying design improvement opportunities, and authoring summary reports.
  • Ensure all clinical engineering deliverables and activities comply with clinical engineering best practices, processes, and tools.
  • Support clinical trials and usability evaluation activities.
  • Support clinical evaluation documentation reviews for EU MDD/MDR, including Clinical Evaluation Plans and Reports, post-market data, and PMCF Plans and Reports.
  • Performs other duties as needed and assigned.

Your Qualifications

Education:

  • BS in engineering (biomedical or related), biosciences and/or nursing required; Master’s degree preferred.
  • or a RN with patient monitoring medical device experience.

 

Qualifications:

  • 5+ years’ experience in the medical device industry, with relevant work experience including clinical/user research, product validation, clinical studies.
  • Experience developing medical devices in regulated industry at all stages from concept through post-market release, patient monitoring experience preferred.
  • Experience as a nurse, or clinical/biomedical engineer in hospital environment is preferred.
  • Demonstrated experience in product validation including successful interaction with the FDA and other regulatory bodies through product approval.
  • Candidates medically trained as a registered nurse, certified respiratory therapist, registered respiratory therapist, clinical engineer, or similar is preferred.

The Dräger Workplace

In North America, Draeger employees over 1,400 employees working in our major sites in the United States and Canada (in the US:  Andover, MA; Telford, PA; Houston / Coppell, TX, and in Canada:  Mississauga, ON), including our Sales and Service workforce employees from coast to coast.

The design, development and manufacturing of Draeger’s Patient Monitoring product line takes place in our Andover, Massachusetts location.

Due to the nature of this position, qualified candidates will be required to be fully vaccinated for Covid-19.  Proof of vaccination will be required as part of the onboarding process. You may be required to carry your vaccination card when on-site at client customers.

Equal Opportunity Employer – Disability and Veteran

Who we are

Draeger is a leading international company in the fields of medical and safety technology. Whether in clinical applications, in industry, mining or emergency services: Draeger products protect, support and save lives. That's what our more than 15,000 employees have been striving for - every day for more than 130 years.  Dräger - Technology for Life ®

What we offer

  1. Additional/Voluntary Insurance
  2. Education & Training
  3. Health center and gym
  4. Health Insurance
  5. Retirement Savings
  6. Special Assistance
  7. Time Away
  8. Workplace Wellness

Additional/Voluntary Insurance; Education & Training; Health center and gym; Health Insurance; Retirement Savings; Special Assistance; Time Away; Workplace Wellness

Interested?

Please apply directly through our career portal.
We look forward to receiving your application.

If you have any questions, please contact

The Dräger image movie

Employee Testimonials
Employee Testimonials
Let’s be social
Let’s be social