What are the responsibilities and job description for the Senior Development Quality Engineer - Medical Device position at Collabera?
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Pay Range: $44 to $47 an hour.
Industry: Medical Device
Contract Duration: 12 Months (Possibility of Extension)
Job Summary:
We are seeking a Senior Development Quality Engineer to support product development activities within a regulated medical device environment. This role is responsible for ensuring quality is built into the design and development lifecycle through strong collaboration with cross functional teams. The position focuses on design controls, risk management, and verification and validation activities to ensure product safety and compliance. The ideal candidate will bring hands on experience in medical device quality engineering and a strong understanding of regulatory standards. This is a high impact role contributing to product quality, patient safety, and successful commercialization.
Key Responsibilities:
- Lead and support completion of design control deliverables to meet project timelines.
- Collaborate with cross functional teams to define measurable and verifiable product requirements.
- Plan and execute design verification and validation activities ensuring compliance with quality standards.
- Lead risk management activities throughout the product lifecycle from concept to commercialization.
- Develop and validate test methods to support product evaluation and performance.
- Support manufacturing process development and qualification for new products and design changes.
- Assist in defining component specifications and supplier qualification processes.
- Support biocompatibility and sterilization validation activities.
- Participate in audits and drive continuous improvement within the quality management system.
- Ensure adherence to regulatory requirements and internal quality processes.
Required Qualifications:
- Bachelors degree in Engineering or related technical field
- Minimum 5 years of experience in quality engineering manufacturing engineering or research and development
- At least two years of experience supporting product development activities
- Experience in medical devices and applicable regulatory standards
- Experience with design controls and product development lifecycle
- Experience in test method development and validation
- Experience in risk management including FMEA and risk assessments
Preferred Qualifications:
- Advanced degree in Engineering or related field
- Experience with active implantable medical devices
- Familiarity with requirements management tools such as DOORS
- Experience with issue tracking tools such as JIRA
- Working knowledge of statistics applied to verification and validation
Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401 k retirement plan, life insurance, long term disability insurance, short term disability insurance, paid parking public transportation, paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually AS Applicable
Salary : $44 - $47