Design Assurance Engineer 3

Hologic•Marlborough, MA

About The Position

Hologic empowers people to live healthier lives everywhere, every day. We are the leading Innovator in women's health, helping healthcare professionals around the world diagnose and treat their patients with precision, certainty and confidence. This role will provide design assurance support for new product development and on-market medical devices. The Design Assurance Engineer will be responsible for facilitating the application of design controls while supporting product development, manufacturing-related design changes, maintaining regulatory compliance, implementing improvements for manufacturability, and evaluating cost reduction efforts. The engineer will participate independently on new product development projects, assuring product inputs are clearly defined and that design verification and validation activities are appropriate and compliant. Test method validation will be an element of assuring verification/validation is acceptable. The role also involves participating independently on sustaining product projects, assuring projects are clearly defined and stay on task, confirming product inputs are continuing to be met, and necessary verification, validation, and risk management activities are completed. The engineer will work collaboratively with R&D to coordinate design elements of Risk Management files for products to ensure compliance with applicable standards and internal policies. Additionally, the role involves assessing change requests of products for impact to design and determining supporting information required for the implementation of changes.

Requirements

Experienced with FDA Quality System Regulations, especially Design Control requirements, ISO 13485 and Medical Device Directive
Experienced with ISO 14971, Risk Management
Technical Bachelor Degree, Electrical or Software Engineering preferred
2-5 years’ experience preferably in medical device industry
Experience with capital medical devices with complex electromechanical systems and software preferred
Must follow all applicable FDA regulations and ISO requirements.

Nice To Haves

Familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging, and Biocompatibility standards and requirements.

Responsibilities

Provide design assurance support for new product development and on market medical devices.
Facilitate the application of design controls while supporting product development, manufacturing related design changes, maintaining regulatory compliance, implementing improvements for manufacturability and evaluating cost reduction efforts.
Participate independently on new product development project, assuring product inputs are clearly defined and assuring design verification and validation activities are appropriate and compliant to confirm inputs requirements are met.
Test method validation would be an element of assuring verification/validation is acceptable.
Participate independently on sustaining product projects, assuring project is clearly defined and stays on task, confirming product inputs are continuing to be met, and necessary verification, validation, and risk management activities are completed.
Work collaboratively with R&D to coordinate design elements of Risk Management files for product to assure compliance with applicable standards and internal policies.
Assess change requests of product for impact to design, determine supporting information required for implementation of changes.
Independently assess the health risk of various situations, including deviations, nonconformances, design verification failures, or proposed product changes.
Demonstrate efficient and effective analysis of situation, including problem definition and connection with associated post-market processes.
Carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, training and developing employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.