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Sr. Development Quality Engineer

The Fountain Group LLC

Westford, MA

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JOB DETAILS
SKILLS
Communication Skills, Cross-Functional, Customer Satisfaction, Design Verification, Document Management, FDA (Food and Drug Administration), Healthcare Quality, Leadership, Maintain Compliance, Manufacturing/Industrial Processes, Medical Equipment, Medical Products, Patient Safety, Problem Solving Skills, Process Development, Product Development, Product Lifecycle, Product Support, Product/Service Launch, Quality Assurance, Quality Assurance Methodology, Quality Engineering, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Regulatory Requirements, Requirements Management, Risk Analysis, Risk Management, Safety Compliance, Sterilization, Technical Support, Test Plan/Schedule, Time Management, Validation Plan, Validation Testing, Vendor/Supplier Planning
LOCATION
Westford, MA
POSTED
13 days ago
The Sr. Development Quality Engineer serves as a technical quality representative supporting product development teams. This role provides design quality expertise across the product lifecycle to ensure patient and user safety, regulatory compliance, and customer satisfaction. The position partners closely with cross functional stakeholders to deliver compliant, high quality medical devices from concept through commercialization.
 
Day-to-Day Responsibilities:
  • Lead or support timely completion of design control documentation
  • Collaborate with cross-functional teams to establish clear, measurable, and verifiable product requirements
  • Support design verification and validation planning, execution, and issue resolution activities
  • Lead risk management activities from product concept through commercialization
  • Support test method development and lead test method validation efforts
  • Collaborate with manufacturing on process development and qualification for new or updated designs
  • Support component specification development, supplier sampling plans, and vendor qualification activities
  • Support biocompatibility and sterilization qualifications
  • Participate in audits and continuous quality system improvement initiatives
  • Ensure compliance with Abbott quality systems, FDA, EU MDR, and other applicable regulatory requirements
  • Maintain effective communication with employees, suppliers, contractors, and customers
 
Qualifications:
  • Education: Bachelor’s degree in Engineering or a related technical field (required). Advanced degree in Engineering or a technical field (preferred).
  • Experience: Minimum 2–5 years of experience supporting medical device product development.
  • Top 3 Technical Skills:
    • Design Controls & Risk Management – Proven experience leading and supporting design control deliverables, risk assessments, and FMEAs throughout product development.
    • Verification, Validation & Test Methods – Expertise in test method development, validation, and execution of design verification and validation activities.
    • Medical Device Quality & Regulations – Strong working knowledge of FDA, EU MDR, and medical device quality system requirements, including audits and compliance activities.
  • Additional Requirement: Clear and effective communication skills are a must.
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About the Company

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The Fountain Group LLC

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
WEBSITE
https://www.thefountaingroup.com/

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