Software Design Quality Engineer
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Overview
Remote
On-site
Compensation
$42-$44/hour
Job Description
Our Client, a Medical Device and Healthcare company, is looking for a Software Design Quality Engineer for their Westford, MA location.Responsibilities:
- Lead and/or support on-time completion of Design Control deliverables
- Support the establishment of objective, measurable, and verifiable product requirements
- Support Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activities
- Lead Risk Management activities from product concept through commercialization
- Support test method development and lead test method validation activities
- Support manufacturing process development & qualification for new product and design changes
- Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications
- Support biocompatibility and sterilization qualifications
- Support audits and quality system improvement activities
- Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.
- Comply with client, U.S. FDA, EUMDR and other requirements, as applicable.
- Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.
- Bachelor’s degree in Engineering or Technical Field.
- Minimum of 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 2 years supporting product development.
- Experience in medical devices and associated regulations/standards.
- Experience in test method development and validation
- Experience in preparing risk assessments, FMEA and other risk documents.
- Preferred Qualifications:
- Advanced Degree in Engineering/Technical Field
- Experience in active implantable medical devices.
- Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA).
- Working knowledge of statistics and its application to verification and validation"
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
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FAQs About Software Design Quality Engineer Jobs at Iconma
What is the work location for this position at Iconma?
This job at Iconma is located in Westford, MA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Iconma?
Candidates can expect a pay range of $42–$43.6 per hour for this role.
What employment applies to this position at Iconma?
The employer has not provided this information. This may be discussed during the hiring process.
What is the process to apply for this position at Iconma?
You can apply for this role at Iconma either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.