Your Responsibilities Include:
- Define the development of comprehensive specifications (hardware and/or software) for equipment/software from basic functionality to complex systems such as PLC's, Visual Basic applications, databases, SCADA applications, and systems with FDA defined electronic records and electronic signatures.
- Provide project estimates independently. Review estimates for Engineer I's.
- Submit specification, protocol and report for approvals and documentation control via a Change Request.
- Develop comprehensive software validations and/or equipment qualification protocols per the specification.
- Execute software validation and/or qualification protocols & record results.
- Document communicate and follow-up on software/equipment issues.
- Complete project deliverables per project schedule and monitor project schedule and scope changes to assure team can meet delivery requirements.
- Create documents, links and Change Requests utilizing a Product Data Management system.
- Provide information on FDA/QSR regulations and internal process validation policy with regards to software validations, equipment installation qualifications, electronic records & signatures.
- Develop and review comprehensive validation procedures in compliance with FDA.
- Perform project lead activities on small to large-scale validation/qualification projects. Participate in vendor evaluations.
- Provide guidance, mentoring and training to Engineer I's & II's. Ensure consistency of work among Engineer I's & II's. Provide peer reviews on specifications, protocols and reports.
- Influences and defines functional, departmental and divisional policies & procedures through involvement with cross-functional engineering initiatives.
- Provide leadership role on championing functional best practices.
What We're Looking For:
- Bachelor’s Degree in Engineering Discipline
- 5-9 years direct experience
- Experience in Medical Device manufacturing specifically writing compliance documentation
- In depth knowledge of MS Office tools
- Must have excellent organization, clear verbal and written skills
- Experience working in a SDLC-system development lifecycle
- Hand on skills using navigating equipment user interfaces
- High level attention to detail and ability to support multiple priorities at once
- Must be team-oriented with people skills and positive can-do attitude in dealing with many customers, from various departments (Engineering, R&D, Manufacturing, Regulatory, etc.)
- Experience working in FDA-regulated industry
- Experience working with a regulatory body in an audit
- Performed in a quality role ensuring industry compliance
- Practical knowledge of 21 CFR Part 11 (electronic records/electronic signature)