Sr. Development Quality Engineer

Position Title: Sr. Development Quality Engineer

Work Location: Westford MA

Assignment Duration: 12 months

Work Schedule: 8am–5pm

Work Arrangement: Onsite

The Sr. Development Quality Engineer will serve as a technical representative providing design quality expertise to a product development team. Responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient/user safety, customer satisfaction, and organizational success.

RESPONSIBILITIES

• Lead and/or support on-time completion of Design Control deliverables

• Support the establishment of objective, measurable, and verifiable product requirements

• Support Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activities

• Lead Risk Management activities from product concept through commercialization

• Support test method development and lead test method validation activities

• Support manufacturing process development & qualification for new product and design changes

• Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications

• Support biocompatibility and sterilization qualifications

• Support audits and quality system improvement activities

• Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.

• Comply with Abbott, U.S. FDA, EUMDR and other requirements, as applicable.

• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.

Basic Qualifications:

• Bachelor’s degree in Engineering or Technical Field.

• Minimum of 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 2 years supporting product development.

• Experience in medical devices and associated regulations/standards.

• Experience in test method development and validation

• Experience in preparing risk assessments, FMEA and other risk documents.

Preferred Qualifications:

• Advanced Degree in Engineering/Technical Field

• Experience in active implantable medical devices.

• Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA).

• Working knowledge of statistics and its application to verification and validation"

Main Notes

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 quality systems, FDA, EU MDR, and other applicable regulatory requirements

• Maintain effective communication with employees, suppliers, contractors, and customers.

Applicant Notices & Disclaimers

• For information on benefits, equal opportunity employment, and location-specific applicant notices, click here

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.