Biomedical Engineer - Mahwah, NJ in Mahwah, NJ at Getinge

Date Posted: 6/16/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Mahwah, NJ
  • Experience:
    Not Specified
  • Date Posted:
    6/16/2019

Job Description

Together we can make a difference

At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope – just to name a few.

A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.

Job Function Summary:

Provide direct technical contribution and support towards the development and validation of new Cardiac Assist products and concepts; as they relate to the discipline of Bio-Medical Engineering.

Job Functions: (Primary “essential” duties and responsibilities)

  • Support both the verification and validation testing of algorithmic functions, in both laboratory and animal/clinical based venues.
  • Evaluate existing products and techniques to foster product improvements
  • Support the development of new concepts and methodologies for the control and automation of Cardiac Assist functions; as they pertain to enhancing product automation, performance, safety, as well as reducing cost.
  • Prepare technical documents/presentations needed for communication during product development and for long term product support.
  • Maintain laboratory tools necessary for the assessment and qualification of algorithmic performance of new products and concepts.
  • Propose/implement algorithms, specification and test plans based upon marketing, clinical and test requirements
  • Review software implementation plans for Bio-Med specified functionality and provide technical feedback to the software group.
  • Provide guidance to Directing Management regarding the development/acquisition of new tools, models and test equipment

Required Knowledge, Skills and Abilities:

  • Strong problem-solving, design and technical skills
  • Strong test execution and data acquisition/analysis skills
  • Excellent interpersonal, verbal and written communication skills
  • Detail oriented work habits + good organization skills
  • Ability to complete BME tasks on schedule as a member of cross-functional development teams
  • Ability to take direction and grow under the leadership and oversight of senior engineers & managers
  • Ability to learn new skills quickly with the ideal candidate having background in the following disciplines:
    • Programming and Software Design
    • Numerical Methods and Elements of Algorithmic Design
    • Physiologic Signal Conditioning
    • Human Physiology/Anatomy

Minimum Requirements:

  • M.S. in Biomedical Engineering or M.S. in Electrical or Software with BME minor – A preferred candidate would have 2+ years of related experience with a concentration and experience in the areas of Signals, Systems or Instrumentation.

Quality Requirements:

  • Build Quality into all aspects of work.
  • Ensure compliance to all FDA and Worldwide Quality & Compliance regulations.
  • Must be able to comply with U.S. and Worldwide medical device regulations.
  • Attend the provided Quality & Compliance training.
  • Adopt the “Beyond Compliance Quality Culture” in the work environment.
  • Must practice verbatim compliance with corporate Quality and Regulatory procedures.
  • Must be competent with the Customer complaint reporting procedures.
  • Must be able to promptly report any non-compliance issues to Chief QA, RA, Compliance officer or appropriate administrator, including the Compliance Hotline.
  • Must be competent with 21 CFR 820, 801, 803,806 and any other applicable federal regulations, and Quality standards.
  • Must not be DE-Barred by FDA for work in any Medical Device or Pharmaceutical business.

Environmental/Safety/Physical Work Conditions:

  • Ensures environmental consciousness and safe practices are exhibited in decisions.
  • Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
  • This position requires only moderate physical demands that are associated with an office/laboratory environment.  There is some moderate risk and certain personal precautions that must be taken when working in either a laboratory or clinical environment.  At times, the individual may have to work under stressful conditions to meet key research and product development milestones.

Internal and External Contacts/Relationships

  • Expect frequent interaction with Supervisor/Manager, Engineers, Quality Assurance, Regulatory Affairs, Clinical and Medical Affairs, Marketing and Service
  • Work with high seniority engineers to understand product designs
  • Work/mentor less experienced engineers, co-ops and peers on assigned projects, if applicable
  • Joint discussions/interaction with outside vendors and consultants

Disclaimer:

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

Getinge Group is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.

INDAL

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We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world’s most desired medtech company.