ReadCoor is looking for a Project Engineering Manager with quality management experience to oversee our molecular diagnostic instrument from launch through regulatory approval. The ideal candidate will have managed a complex life science or medical device (diagnostic) through multiples stages of development and preferentially through FDA approval. The candidate will work with our R&D teams in both laboratory science and engineering to deliver our commercial products to the research and clinical markets. Our panomic instrument is the first to highly-multiplex detection of RNA, DNA, proteins, and therapeutics in 3D in the same sample, and will advance research and clinical diagnostics in oncology, infectious disease, cognitive disease, and life sciences broadly.
Duties / Expectations of Role
- Leads quality strategy and scheduling efforts and execution
- Provide leadership to team members on best practices for Verification and Validation execution as it applies to key medical device methodologies, FDA design controls and quality system requirements and ISO and FDA Compliance activities
- Lead all project management activities for sustaining activities, including budgets, schedules and milestones.
- Lead verification plan and protocol reviews. Ensure that verification documents follow guidelines and processes for diagnostic device functionality per the Quality Systems Regulations and ISO standards.
- Design and develop verification tools and systems required to ensure the proper and regulatory compliant operation of molecular diagnostic medical devices.
- You will be responsible for creation and execution of all engineering project plans and change orders (ECOs), including any and all supporting documentation
- Selection and management of QMS
- Develop regulatory-compliant manufacturing documentation that ensures consistent assembly and testing of products.
- Responsible for ensuring execution of corrective actions, ongoing quality improvements, and change control activities
- Lead efforts to address and resolve sustaining engineering issues with internal and external customers
Mandatory Requirements
- A Bachelor’s degree in a relevant engineering or science discipline with at least 7 years of engineering experience in a life sciences, diagnostic or medical device environment is required
- Applies education and experience to develop, maintain and resolve any issues with assigned systems of responsibility.
- Subject matter expert role at all stages -- from converting lab scale technology into a commercial medical product to supporting the released product.
- Familiar with and follows FDA/ISO Design Control principles and regulations in product development
- Strong knowledge of QMS in a regulated environment
- Strong technical background with thorough knowledge of engineering processes, design and materials within a medical device environment
- Experience with verification and validation
- Experience working with interdisciplinary teams to deliver product releases to market
- Knowledge in design control procedures
- ISO9001 experience, 510(k) FDA experience
Nice to Have
- PMP certification
- Software project management
- Software validation
EEO Statement: We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation or any other characteristic protected by law.
Readcoor, Inc. is committed to building a culturally diverse team and strongly encourages applications from female and minority candidates.
All applicants should be legally entitled to work for any employer in the US.
Note to Employment Agencies: The company will not be responsible for any fees related to resumes that are unsolicited. Thank you!