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Sr. Development Quality Engineer

Lancesoft

Westford, MA

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JOB DETAILS
SALARY
$40
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
14 days ago
Title: Sr. Development Quality Engineer
Location: Westford, MA 01886
Duration: 10 Months

Position Purpose and Scope:
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.
Top 3 Technical Skills:
1. Design Controls & Risk Management Proven experience leading and supporting design control deliverables, risk assessments, and FMEAs throughout product development.
2. Verification, Validation & Test Methods Expertise in test method development, validation, and execution of design verification and validation activities.
3. 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.
Education:
Bachelor s degree in Engineering or a related technical field (required).
Advanced degree in Engineering or a technical field (preferred).
Experience / Project Details:
Minimum 2 5 years of experience supporting medical device product development
Project focus: Class II imaging device
This role will support new product development, with multiple imaging-related projects in progress
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 Client quality systems, FDA, EU MDR, and other applicable regulatory requirements
Maintain effective communication with employees, suppliers, contractors, and customers

About the Company

L

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/

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