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Full-timeDescriptionThe Senior Sustaining Engineer is responsible for ensuring the continued manufacturing of existing products, addressing any issues that arise, and gaps in documentation, as well as identifying and implementing design and process changes to enhance existing product performance, COGS and compliance. This is an on-site position located in Rockville, MD.
- Identify and qualify alternate sources of components to ensure continued production.
- Identify opportunities for continuous improvements and implement design and process changes to enhance performance, reliability, manufacturability and cost.
- Develop and execute test plans to validate design and/or process changes and ensure product performance meets specifications. Conducts appropriate risk analysis as required
- Maintain and update design history files (DHF) and device master records (DMR) to reflect changes and improvements. Identify gaps in existing product documentation and propose and implement mitigations.
- Coordinate roll out of software upgrades (including security patches) with the product development team.
- Lead technical support activities to facilitate quality investigations, root cause analysis, reproducing customer issues and corrective action/preventive action (CAPA) implementation.
- Interface with Technical Support and/or customers to understand needs and address any product-related concerns.
- Work closely with Product Development, Product Management, Quality, Manufacturing, and Regulatory teams to ensure seamless implementation of product changes.
- Estimate project costs, scheduling, and execute against plans. Lead cross-functional teams as required.
- Supports internal and external audits and quality system certification.
- Provides training, technical support, and application customization at customer and/or contract manufacturer sites.
- Ensure all changes comply with internal change control procedures and external standards such as ISO 9001, ISO 13485 and FDA GMP requirements.
- Conducts all activities in compliance with Standard Operating Procedures outlined in MaxCyte’s Quality Management System.
- Complies with all applicable policies regarding health, safety, and environmental policies.
Requirements
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field. A Master’s degree is preferred.
- Minimum of 5-7 years of experience in sustaining engineering or a similar role within the medical device/biotech/pharma or other regulated industry. Hands-on experience with troubleshooting product and process issues preferred.
- Proficiency in CAD software (e.g., SolidWorks), knowledge of manufacturing processes (e.g., machining, assembly, injection molding), and understanding of medical device regulations (ISO13485, 21CFR820) a plus.
- Strong analytical and problem-solving skills with a proven track record of resolving complex technical issues.
- Experience with applying LEAN manufacturing principles and statistical tools (e.g., Minitab) to develop robust solutions. Lean Six-Sigma training/certification preferred.
- Experience with design transfer activities and automation equipment preferred.
- Familiarity with software change management and V&V preferred.
- Experience in working against a plan required. Project Management training/certification preferred.
- Demonstrated computer skills; experience using MS Office (Word, Excel, PowerPoint), MS-Project preferred.
- Able to work on multiple tasks effectively, has a “do what it takes” attitude to meet customer deadlines.
- Excellent verbal and written communication skills, with the ability to effectively collaborate with cross-functional teams.
- Minimum travel – less than 10%.
Note: To the extent permissible under applicable law, candidates will be required to show proof of being fully vaccinated against COVID-19 upon commencing employment. Reasonable accommodations will be considered on a case-by-case basis for exemptions to this requirement in accordance with applicable law.
