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Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed Designs and installs sophisticated testing equipment and performs product testing and analysis to maintain quality levels and minimize defects and failure rates Analyzes reports and defective products to determine trends and recommend corrective actions Collaborates with supplier representatives on quality problems, ensures that effective corrective actions are implemented, and contributes to supplier quality improvement programs
The Medical Device Design Assurance Engineer will initially focus on accelerating technical deliverables related to medical device design and development. The Medical Device Design Assurance Engineer may also provide support to the Quality organization for pilot manufacturing quality initiatives and limited post market activity. This role will be embedded in an emerging business with a dynamic and exciting growth path.
Review, create and edit technical files and design control documents for medical devices with integrated hardware and software in accordance with QMS system and applicable regulations
Interact with of cross functional divisions and research and development groups to jointly develop objectives and align on product development plans
Participate in meetings and efforts to gather data and work towards resolution of project development and launch issues as they relate to areas of DAE expertise
Prepare and review design verification test protocols, procedures and reports
Drive risk management file activities and updates inclusive of hazard analysis and DFMEAs and the inform risk management approach for engineering
Assist engineering in the compilation of design history files in accordance with ISO 13485, ISO14971 Risk Management and IEC 60601 or other applicable USFDA and EUMDD regulations
Assure all applicable quality decisions are derived from the appropriate risk management document in accordance to the QMS as well as safety, reliability and international compliance of Company medical device products
Support potential ISO 13485 certification, CAPAs and audits (internal and external)
Work with Joint Development Manufacturing (JDM) partners to establish design assurance requirements, including validation testing and product certification standards, and oversee their successful execution.
Participate in product changes, project reviews, and relevant project meetings
Ensure that design and process changes are engineered and manufactured in conformance with product requirements, required standards and regulations.
Review and approve design control documents and design changes
Support, as needed, external audits (registration, regulatory)
Provide expertise, guidance and training within area of responsibility to the organization
Performs other duties as assigned.
Ensure compliance with our Quality Management System, 3rd accreditation, FDA regulatory requirements
BS in Engineering, Bioengineering with at least 5 years of experience working with medical device design FDA, ISO or other regulated environment and/or equivalent combination of education and experience.
Experience in product & process development
Proficient with medical device product and process risk management
Team oriented with solid communication and coaching skills
Company is an equal opportunity employer that is committed to inclusion and diversity. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or any other legally protected characteristics.
Company is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the application or employment process, please send an e-mail and let us know the nature of your request and your contact information.
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