Senior Sustaining Engineer
2 days ago
The Senior Sustaining Engineer will play a critical role in ensuring the continued manufacturing of existing products, addressing any issues that arise, and gaps in documentation. This position will also identify and implement design and process changes to enhance existing product performance, COGS, and compliance.
Key Responsibilities- Identify and qualify alternate sources of components to ensure continued production.
- Develop and execute test plans to validate design and/or process changes and ensure product performance meets specifications.
- Maintain and update design history files (DHF) and device master records (DMR) to reflect changes and improvements.
- 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.
- Support internal and external audits and quality system certification.
- Provide training, technical support, and application customization at customer and/or contract manufacturer sites.
- 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.
- 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.
- 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.
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Senior Sustaining Engineer
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Rockville, Maryland, United States MaxCyte Inc Full timeJob SummaryThe Senior Sustaining Engineer will play a critical role in ensuring the continued manufacturing of existing products, addressing any issues that arise, and identifying opportunities for continuous improvements. This position is located in Rockville, MD and requires a strong analytical and problem-solving skills with a proven track record of...
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Senior Sustaining Engineer
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Rockville, Maryland, United States MaxCyte Inc Full timeJob DescriptionSenior Sustaining Engineer Role Summary:The Senior Sustaining Engineer is a critical member of the MaxCyte Inc. team, 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...
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Senior Sustaining Engineer
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Rockville, Maryland, United States MaxCyte Inc Full timeAbout the Role:The Senior Sustaining Engineer at MaxCyte Inc. 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.Key Responsibilities:Alternate...
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