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Our client, located in Baltimore, MD is seeking an experienced Engineer to provide technical leadership in manufacturing process development and design transfer of their artificial pump lung design used for Extracorporeal Membrane Oxygenation (ECMO). This medical device includes a single use disposable and an electro-mechanical durable component. Responsibilities will include working through all aspects of the development process including requirements definition, design for manufacture, implementation, test, qualification and documentation. Experience with medical device disposables, robotic gluing, curing and potting process is a plus. Excellence in working in a team that includes internal, contracted and vendor resources is essential.
Responsibilities and Duties
- Expert and technical lead on manufacturing process flow and design transfer
- Lead manufacturing fixture development, process development and qualifications
- Lead process development and optimization of critical fabrication
- Author and maintain manufacturing specifications, requirements, and Failure Modes and Effects Analyses (FEMA) in accordance with protocols and FDA guidance documents
- Author and lead process qualification via IQ, OQ & PQ process
- Expert technical lead on design transfer in partnership with contract manufacturers.
- Conduct and lead failure investigations.
- Ensure document management and manufacturing control compliance.
- Conduct and manage structured design reviews.
- Work as an integral member of the product development team throughout the product lifecycle, working with hardware, software and firmware engineers, user experience specialists and system engineers
Qualifications and Skills
- Familiarity with modern verification/validation methods
- Knowledge of manufacturing documentation, engineering test protocols, engineering laboratory procedures.
- Knowledge of Six Sigma Tools (DFSS and/or DMAIC)
- Experience with managing and communicating with outside suppliers, manufactures and consults is essential.
Experience and Education Requirements
- BS Engineering
- Minimum 10 years of experience in a regulated design and development or manufacturing/operational environment.
- Strong PC skills and statistical analysis
- Medical device development experience
- Knowledge of quality systems, ISO 13485, and FDA QSR for medical devices.
- Knowledge of Standards Applicable to Medical Device Safety Risk Management (ISO 14971, IEC 60601-1:2005, etc.)
- Team player with a great attitude
- Excellent communication skills
Competitive benefits package including medical, dental, vision, and 401k match.
Job Type: Full-time
- Engineering: 10 years
Job Type: Full-time
Salary: $120,000.00 to $125,000.00 /year
You have requested that Indeed ask candidates the following questions:
- How many years of Manufacturing Engineering experience do you have?
- How many years of Medical Device Development experience do you have?
- Have you completed the following level of education: Bachelor's?