Design Assurance Engineer 2

Hologic, Inc.; Marlborough (MA); On-site; USD 78,000 - 122,000; Full time

Job summary

Hologic, Inc. in Marlborough, MA, seeks a Design Assurance Engineer 2 to provide design assurance support for new product development and on-market devices, ensuring design controls, verification and validation, risk management, regulatory compliance, and change activities throughout the product lifecycle.

The role collaborates with R&D and project teams to define product inputs, ensure verification and validation meet requirements, and support health risk assessments for on-market products,

Qualifications

• Experience applying design controls to medical device development and sustaining activities.
• Ability to review and ensure compliance of project documentation.
• Familiarity with FDA QSR, ISO 13485, and ISO 14971 risk management requirements.
• Knowledge of verification and validation requirements for regulated products.

Responsibilities

• Provide design assurance support for new product development and on-market medical devices.
• Facilitate application of design controls throughout product development and sustaining activities.
• Support regulatory compliance, manufacturability improvements, and cost-reduction evaluations.
• Coordinate design elements of Risk Management files with R&D and project teams.
• Assist in health risk assessment activities for on-market products as needed.
• Analyze product issues, define problems, and evaluate impact for change requests.

Skills

Design controls

Regulatory compliance

Risk assessment

Verification & validation

Documentation

Cross-functional collaboration

Communication

Education

Technical Bachelor's Degree

Job description

Design Assurance Engineer 2 will provide design assurance support for new product development by ensuring that design controls, verification and validation, risk management, regulatory compliance, and product change activities are effectively implemented and maintained.

Responsibilities

• Provide design assurance support for new product development and on-market medical devices.
• Facilitate application of design controls throughout product development and sustaining product activities.
• Support manufacturing-related design changes, regulatory compliance, manufacturability improvements, and cost-reduction evaluations.
• Participate in new product development projects by ensuring product inputs are clearly defined and that design verification and validation activities confirm requirements are met.
• Support test method validation as part of verification and validation activities.
• Participate in sustaining product projects by ensuring projects are well-defined, remain on task, and include required verification, validation, and risk management activities.
• Collaborate with R&D to coordinate design elements of Risk Management files and ensure compliance with applicable standards and internal policies.
• Coordinate Health Risk Assessment activities for on-market products, with manager or lead support as needed.
• Analyze product issues efficiently, including defining problems and evaluating potential impact.
• Assess product change requests for design impact and determine required supporting documentation for implementation.

Knowledge

• FDA Quality System Regulations, especially Design Control requirements.
• ISO 13485 and Medical Device Directive requirements.
• ISO 14971 Risk Management requirements.
• Verification and validation requirements for regulated products.
• Requirements analysis, including development of measurable and testable specifications.
• Familiarity with usability, reliability, electrical safety, software, sterilization, packaging, and biocompatibility standards.
• Preferred knowledge of test method validation, root cause failure analysis, statistical methods, and design of experiments.

Skills

• Ability to support design control activities in a regulated medical device environment.
• Ability to review and assess product and project documentation for compliance.
• Strong analytical skills for evaluating product issues, risks, and design change impacts.
• Ability to coordinate cross-functional activities related to risk management and health risk assessments.
• Effective project team participation and collaboration.
• Clear communication of compliance assessments and technical findings.
• Ability to define, review, and evaluate verification and validation requirements.

Behavior

• Collaborative and team-oriented, especially when working with R&D and project teams.
• Detail-oriented with a strong focus on compliance and documentation quality.
• Proactive in identifying design, regulatory, and risk-related concerns.
• Objective and analytical when evaluating product issues and change requests.
• Organized and able to keep projects focused and on task.
• Acting as a compliance advocate while maintaining effective communication with stakeholders.

Experience

• Technical Bachelor’s Degree is required.
• 2+ years of experience preferred, ideally in the medical device industry.
• Experience supporting regulated product development, sustaining engineering, or design assurance activities is preferred.

Why join Hologic?

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $78,000 - $122,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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