The primary responsibility of this position is to assume a lead role in providing Quality Engineering support for New Product Development projects. The Design Quality Engineer is responsible for facilitating compliance to applicable internal and external requirements during the product development cycle and commercialization of new products.
- Design Control Activities. Be the design quality engineering resource for design projects:
- Collaborate with Design teams, provide technical support, and facilitate the successful execution of the Design Control Process for complex electromechanical medical devices containing hardware, software, electrical and mechanical components.
- Responsible for Quality Engineering deliverables required within the product development process.
- Support Design Verification and Validation activities, including review of verification & validation protocols and reports
- Assist in the analysis of product requirements and specifications. Participate in product design reviews and team meetings.
- Provide subject expertise and input in the following areas: Biocompatibility strategy, including requirements, protocol, and report; Shelf-Life Studies strategy, including accelerated and real-time; Cleaning Validation.
- Interface with all departments to provide leadership on the use of Quality Engineering methodologies, tools, regulatory compliance requirements.
- Ensure that technical information is accurate and in compliance with quality and regulatory requirements.
- Review Design Changes post design transfer.
- Risk Management Activities:
- Maintain and manage the overall site Risk Management process in accordance with ISO 14791 and other applicable standards. Work cross-functionally with the Subject Matter Experts from R&D, Clinical, and Operations to ensure a comprehensive risk management process.
- Manage maintenance of Risk Management Files post design transfer.
- Usability Activities:
- Provide quality support for the development of User Needs, Usability plans, reports and files.
- Ensures User Needs are mapped to appropriate Design Inputs
- Implement Design Control/Risk Management process improvements to ensure a more effective, efficient, and compliant processes.
- Conduct DHF Audits throughout the development process
- Develop Quality Plans
- Maintain and Manage the DHF after product commercial release
- Ensure that technical information is accurate and in compliance with international regulatory requirements.
- Perform all duties with minimal oversight required from direct manager.
Additional responsibilities include: generating and revising relevant procedures, preparing and analyzing quality trend data, supporting the resolution of CAPAs to closure and verification of effectiveness, and participation in internal and external audits.
- Bachelor’s degree in science or engineering.
- Minimum of 5 years of quality engineering or related experience in an FDA regulated medical device environment.
- Proficiency with medical device development life cycles and Design Control processes preferred.
- Ability to handle complex issues and exercise judgement, based on experience, with minimal oversight from manager.
- Knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971
- Knowledge of IEC 62366, IEC 60601, Biocompatibility, and Aging Studies preferred
- Understanding of Medical Device software requirements preferred but not required.
- Ability to write Verification / Validation protocols and reports.
- Problem solver.
- Six sigma green belt and/or ASQ CQE preferred.
- Competent using office software including MS Word, Excel, PowerPoint, and Outlook.
- Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally with internal and external partners and regulatory bodies.
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to apply sampling plans and statistical methods for data analysis.
- Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)
Travel: Yes, 5 % of the Time
Job Type: Experienced