Senior Design Assurance Engineer


The Judge Group

2020-10-12 20:19:40

Job location Mahwah, New Jersey, United States

Job type: fulltime

Job industry: Other

Job description

Location: Mahwah, NJ
Description:

Job Title: Senior Engineer, Engineering

Location: Mahwah, NJ

Duration:- 12 Months

Job Summary/Description -

Senior Design Assurance Engineer: - 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

Additional Job Details:

Qualifications, Knowledge and Skills: - 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 proven track record of meeting deadlines.

Purpose for Request:

Support to prepare for pending EU MDR regulation:

Thanks & Regards,

Puja Prakriti, Technical Recruiter, The Judge Group

151 S. Warner Rd, Suite 100, Wayne, PA 19087

( | Toll-free (1 ext. 123

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