Job description
Looking for a Senior Engineer for a company in Westford.
(Direct Hire) 135K-145K
Position Overview:
(Direct Hire) 135K-145K
Position Overview:
- Sr. Engineer - Compliance - Westford, MA (Hybrid -on-site 2-3 days a week with flexibility)
- Local travel required for lab/agency testing
MUST HAVE:
- Medical Device Experience and a Solid understanding of IEC60601-1 standards.
Qualifications:
- Bachelor's degree is equivalent to three (3) years of experience
- 5+ years relevant experience in compliance, product development design, operations or quality role.
- Minimum 3 years' experience with medical device compliance associated with commercial capital equipment and accessories.
- Laser and RF experience
- Prior experience working for (or with) NRTL agencies.
- Knowledge of emissions and immunity engineering practices
- Expertise developing medical devices in compliance with IEC60601-1 (and associated particular and collateral standards), Environmental regulation, FDA 21 CFR 820, CDRH, ISO13485, EU MDR.
- Proficiency in report writing, analysis, and compliance procedures.
- Thorough understanding of regulatory frameworks.
- Skilled in business operations or project management.
- The ability to communicate complex ideas verbally and in writing.
- Solid technical knowledge and understanding of product/process design.
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