Design Assurance Engineer 2

Hologic•Marlborough, MA

15h

About The Position

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.

Requirements

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.
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.
Technical Bachelor’s Degree is required.

Nice To Haves

Preferred knowledge of test method validation, root cause failure analysis, statistical methods, and design of experiments.
Experience supporting regulated product development, sustaining engineering, or design assurance activities is preferred.

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.