Senior Sustaining Engineer

4 days ago

Rockville, Maryland, United States MaxCyte Inc Full time
Job Title: Senior Sustaining Engineer

MaxCyte Inc is seeking a highly skilled Senior Sustaining Engineer to join our team. As a key member of our engineering team, you will be responsible for ensuring the continued manufacturing of existing products, addressing any issues that arise, and identifying and implementing 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.
  • Supports internal and external audits and quality system certification.
  • Provides training, technical support, and application customization at customer and/or contract manufacturer sites.
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%.

MaxCyte Inc is an equal opportunity employer and welcomes applications from diverse candidates. 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.

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