Quality Development Engineer II
Responsible for supporting design and development, technical maintenance, and manufacturing of the company’s current and future electrical therapy devices and consumable products.
Responsible for developing risk management documentation to address product design and process changes, product and process quality issues, and compliance issues. You will review and approve change order packages, design verifications, design validations, and process validation activities.
ESSENTIAL JOB DUTIES/RESPONSIBILITIES:
- Act as quality engineering lead for the design and development/on-market support of OncoSec’s electroporation devices and consumable products, facilitating the application of design/change controls, risk management, quality plan, and implementation of design and development plan
- Plan and lead design assurance (premarket quality) across various phases of medical device product development, including design and development planning, requirements definition, root cause analysis, test method development, design verification/validation, and design transfer
- Collaborate in the writing of design requirements and specifications, Verification and Validation plans and protocols, and traceability matrices
- Supports with design, testing, and documentation activities during medical device development
- Responsible for project quality plan and implementation of quality practice in all projects
- Review and approve user requirements, system requirement specifications, software requirement specifications, hardware requirement specifications, functional requirements, and test cases
- Supports and reviews design verification, design validation, and design history file (DHF) creation and maintenance
- Support software, firmware device development, software development life cycle, and defect management activities in compliance with IEC 60601 and IEC 62304 standards
- Support device regulatory filings, master file amendments, responses to questions, etc.
- Organize, host, and facilitate risk management-related activities and design reviews with the project teams and ensure compliance of such activities to the applicable standards and regulations
- Work with the development team to ensure that all reasonable failure modes are identified, develop mitigations for failure modes, and verify the effectiveness of these mitigations
- Create and maintain risk management files such as UFMEA/DFMEA/PFMEA that are compliant with the requirements of ISO 14971
- Responsible for all aspects of design and development quality assurance and compliance to 21 CFR 820, ISO 13485, ISO 14971, EU CE Certification, and other applicable requirements
- Responsible for ensuring both compliance and effectiveness of new products and manufacturing processes
- Provides Quality oversight of external facilities, such as CMO organizations, vendors, and other related partner companies
- Represent premarket quality on project teams to ensure applicable standards and regulations for the products being brought to the market are incorporated throughout the development lifecycle
- Provides support in problem-solving, NCR, CAPA procedures, etc., by performing investigations, conducting root cause analysis, developing, and implementing plans to resolve.
- Manage quality turnarounds, renewals, and changes that impact customer satisfaction and Regulatory expectations.
- Assist with associated activities, such as CMO supply chain, harmonized QA programs across Clinical, Device, IT, R&D, etc.
- Works collaboratively with the Director of Quality Assurance to support all site business goals
- Develop and implement the programs and processes to maintain a superior and consistent level of quality performance across the device organization
- Be the expert in the execution of device quality systems and operational excellence initiatives that enhance compliance, performance, improve quality, reduce cost, and generate sustainable quality improvement
- Develop the San Diego facility into a commercial device entity, co-hosting global regulatory inspections with a high degree of success
- Ensures design and development activities have a smooth hand-off to contract manufacturing sites
- Provides quality engineering support for other departments as necessary
- Bachelor’s degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or other related engineering disciplines with a minimum of 5 years’ applicable medical device development job experience including internships
- Or master’s degree with a minimum of 3 years of relevant medical device development experience including internships
- Preferred a minimum of 5 years of hands-on risk management experience in developing and maintaining risk management files such as UFMEA/DFMEA/PFMEA, Plans, Reports, etc.
- Preferred minimum of 5 years of quality engineering experience (design controls/change control, design/process validation, and risk management) in a regulated medical device environment
- Experience reviewing and approving plans and reports for design verification, design validation, and process validations required
- Experience reviewing and approving Device Master Record (DMR) documents required
- Regulatory audit experience is preferred
- Experience working with electrical and mechanical design
- Experience working with software design, architecture, verification, unit/integration testing, etc. is preferred
- Understanding of regulatory requirements as established by FDA, CE, and ISO
- Strong problem-solving skills
- Ability to maintain awareness and control of quality, scope, and schedule to ensure on-time delivery of the project
- Excellent teamwork skills
- Excellent written and verbal communication skills
- Ability to work independently and in small groups within a fast-moving, demanding, and changing environment
- Ability to work to deadlines and prioritize projects
- Experience coordinating QA activities with the support of a medical device contract manufacturer
- Process, QMS, or supplier auditing experience desired
- Lean Six Sigma (Black or Green Belt), Certified Quality Engineer, Certified Quality Auditor desired.
- Knowledge of FDA QSRs, IEC 60529, IEC 60601-1 suite, IEC 62304, IEC 62366-1, RoHS, REACH, WEEE, ISO 13485, ISO 14971 standards and GMP, GLP requirements
- Knowledge of computers and software programs including Word, Excel, Access, Visio, MS Project, Minitab, and PowerPoint
Learns to use professional concepts. Applies company policies and procedures to resolve routine issues. Works on problems of limited scope following standard practices and procedures to analyze situations or data.
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk, or hear in a standard office environment. In a lab setting, occasionally use hands to finger, and handle objects, tools, or controls. The employee must occasionally lift and/or move up to 20 pounds.
To apply, email your resume and cover letter to [email protected]. In the subject line of your email, please enter the exact name of the position for which you’re applying.