This role will focus on the design and development of clinical and commercial Class II devices. The successful candidate will join the Quality Team and work closely with Product Development, Quality Control, Regulatory Affairs, and Manufacturing Functions, as required.
Responsibilities:
- Provides quality assurance support in the design and development of combination medical device products, facilitating the application of design controls and risk management.
- Supports Design History File establishment, creation, approval, and maintenance
- Supports Design History File audits at Phase Gates to ensure product development projects comply with applicable design control regulations (21 CFR 820) and company policies and procedures.
- Reviews and approves design documentation including, but not limited to, verification and validation methods, test plans, protocols and reports, test and inspection documents, design engineering drawings, statistical analysis methods, and risk documents (design and process).
- Familiar with Risk Analyses, including d.F.M.E.A., u.F.M.E.A., and p.F.M.E.A. Able to present to Cross-Functional Team for input, revision, and closure. Must be familiar with U.S. FDA and E.U. Risk Analysis methods, as well as those of other regulatory jurisdictions.
- Reviews new and modified product designs for quality characteristics, including manufacturability, testability, reliability, biocompatibility, sterility, and conformance to product requirements.
- Supports Change Control, works with the Cross-Functional Team for Impact Assessment, and ensures the timely completion of activities while updating relevant documents in the Design History File.
- Supports the technical aspects of New Product Commercialization by effectively utilizing product knowledge and first-generation learnings to inform the efficient Design and Development of subsequent product generations.
- Familiar with Root Cause Analyses relating to Process and Product Development. In addition, with cross-functional input, authors and supports study protocols and applicable testing regimens, and documents all Root Cause Analysis Reports.
- Performs Design History File Remediation as required, including, as applicable, review and revision of all Design and Quality System Documentation.
- Investigate product complaints and reported quality issues to ensure closure in accordance with company guidelines and external regulatory requirements.
- Supports vendor management and third-party auditing assessments.
- Supports Master Batch Records and other vendor documentation required for product release.
Qualifications:
- MS with 3+ years, or B.S with 5+ years of experience. Degree in Engineering
- Minimum of 2-5 years of experience working within a regulated medical device environment.
- Experience with device-biologic combination products
- Proven experience with Medical Device Product Development, ownership and authorship of Design History Files, leading Device Risk Management initiatives, and Lifecycle Management.
- Working knowledge of Process Instrumentation and Controls, development and characterization of Test Methods for selection, verification and validation of components, sub-systems and assemblies.
- A thorough understanding of c.G.x.P principles and practices, ISO 13485, ISO 14971, and 21C.F.R.820.
- A strong understanding of statistical principles is required, as are strong technical writing and presentation skills.
- Must be able to work independently with adequate supervision, multi-task and support several projects simultaneously.
- Must demonstrate strong interpersonal and teamwork skills.
