Job Description
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
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
Numbers & Facts
| Location | Westford, MA |
| Industry | Staffing/Employment Agencies |
| Salary | $40 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
About Company
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).Â
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.
Skills
- Communication Skillsunmatched
- Cross-Functionalunmatched
- Customer Satisfactionunmatched
- Design Verificationunmatched
- Document Managementunmatched
- FDA (Food and Drug Administration)unmatched
- Healthcare Qualityunmatched
- Leadershipunmatched
- Maintain Complianceunmatched
- Manufacturing/Industrial Processesunmatched
- Medical Equipmentunmatched
- Medical Productsunmatched
- Patient Safetyunmatched
- Problem Solving Skillsunmatched
- Process Developmentunmatched
- Product Developmentunmatched
- Product Lifecycleunmatched
- Product Supportunmatched
- Product/Service Launchunmatched
- Quality Assuranceunmatched
- Quality Assurance Methodologyunmatched
- Quality Engineeringunmatched
- Quality System Requirements (QSR)unmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Regulatory Requirementsunmatched
- Requirements Managementunmatched
- Risk Analysisunmatched
- Risk Managementunmatched
- Safety Complianceunmatched
- Sterilizationunmatched
- Technical Supportunmatched
- Test Plan/Scheduleunmatched
- Time Managementunmatched
- Validation Planunmatched
- Validation Testingunmatched
- Vendor/Supplier Planningunmatched
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