Career opportunity in Biomedical Engineering in New Jersey

If you are looking for career opportunities in biomedical engineering, here is the best career opportunity in New Jersey for Biomedical Engineers.

Vacancy Name:

                                           Senior Design Assurance Engineer

                                 TOP medical device company in Mahwah, NJ

Job description:


– Analyze post-market data to identify any potential safety signals that may alter the benefit-risk assessment of product on the market
– Update Risk Management Files if necessary
– Conduct remediation activities on existing Risk Management Files to ensure compliance to ISO 14971
– Development of PSURs in preparation for the EU MDR Transition

-risk assessment of product on the market
– Update Risk Management Files if necessary
– Conduct remediation activities on existing Risk Management Files to ensure compliance to ISO 14971
– Development of PSURs in preparation for the EU MDR Transition

Qualifications, Knowledge and Skills Requirement:

Bachelor’s Degree in Engineering or related field of study.
2+ years of experience as a Reliability or Quality Engineer in a regulated design environment.
– Prefer experience with medical device product development life cycle, including risk management and design verification & validation
– Knowledge of FDA QSR, EU MDR, ISO 13485 Design Control Procedures and ISO 14971
– Demonstrated ability to effectively work cross
– functionally with other departments including Product Development, Regulatory and Clinical.
– Demonstrated problem-solving and troubleshooting skills.
– Demonstrated interpersonal and communication skills.
– Demonstrated a positive, energetic approach to teamwork.
– Demonstrated ability to learn quickly and multi-task – Demonstrated ability to respond to the urgent needs of the team, with a proven track record of meeting deadlines.

– 2+ years of experience as a Reliability or Quality Engineer in a regulated design environment.
– Prefer experience with medical device product development life cycle, including risk management and design verification & validation
– Knowledge of FDA QSR, EU MDR, ISO 13485 Design Control Procedures and ISO 14971
– Demonstrated ability to effectively work cross functionally with other departments including Product Development, Regulatory and Clinical.
– Demonstrated problem-solving and troubleshooting skills.
– Demonstrated interpersonal and communication skills.
– Demonstrated a positive, energetic approach to teamwork.
– Demonstrated ability to learn quickly and multi-task
– Demonstrated ability to respond to the urgent needs of the team, with a proven track record of meeting deadlines.

Click Here to Apply >> Apply

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