Senior Sustaining Engineer
Company: MaxCyte Inc
Location: Rockville
Posted on: October 18, 2024
Job Description:
Description:
The 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.
PIe54d3fb6d4af-37248-35559685
Keywords: MaxCyte Inc, Rockville , Senior Sustaining Engineer, Engineering , Rockville, Maryland
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