Sr. Design Assurance Engineer - Risk Management

Hologic•Marlborough, MA

6h•$97,600 - $152,700

About The Position

We are looking for a seasoned, experienced professional who works on problems of diverse scope, evaluates data and identifiable factors, applies judgment in selecting methods and techniques, and resolves a wide range of issues creatively with limited day-to-day instruction. The role requires extensive integrated knowledge of assigned products to support medical device quality, compliance, and safety throughout the product lifecycle, from product development through market and post-market follow-up.

Requirements

Extensive integrated knowledge of assigned products.
Knowledge of design controls, including application of design controls for manufacturing and design changes.
Knowledge of risk management, including implementation and maintenance of risk management throughout the device product lifecycle.
Knowledge of quality systems, including support for internal and external audits, NCEs, CAPAs, SSEs, QPLs, complaint investigation, and post-market surveillance.
Knowledge of product and design requirements, ensuring requirements are properly established, qualified, and met.
Knowledge of regulatory standards, including FDA Medical Devices 820 Quality System Regulation, ISO 13485, ISO 14971:2019, EU MDD 93/42/EEC, and EU MDR 2017/745. Good Laboratory Practices, usability, reliability, electrical safety, and software standards and regulations.
Knowledge of verification and validation requirements for regulated products.
Knowledge of requirements analysis, including development of testable and measurable specifications.
Knowledge of test method validation, root cause failure analysis, statistical methods, and design of experiments.
Ability to drive action according to Deming Cycle / PDCA principles.
Strong written, verbal, and technical writing communication skills with fluent written and verbal English.
Strong presentation skills.
Ability to work effectively on project teams and take leadership on critical tasks to ensure timely completion or resolution.
Ability to assess written product and project documentation as an advocate for compliance and communicate assessments effectively.
Bachelor’s Degree, preferably in Engineering, Biomedical, or a related field.
Prior experience in medical device or other highly regulated industry.
Experienced with FDA-Medical Devices-820 Quality System Regulation, especially Design Control requirements, ISO 13485 Medical Device Quality management System, ISO 14971:2019, Risk Management, Directive (ED)93/42/EEC (MDD) European Union Medical Device Directive, Regulation (EU) 2017/745 (MDR) European Union Medical Device Regulation.
Experienced with Good Laboratory Practices.
Experienced with Usability, Reliability, Electrical Safety and Software standards and regulations.

Nice To Haves

Master’s Degree or PhD

Responsibilities

Support medical device quality, compliance, and safety throughout the product lifecycle.
Apply design controls for manufacturing and design changes.
Implement and maintain risk management throughout the device product lifecycle.
Support internal and external audits, NCEs, CAPAs, SSEs, QPLs, complaint investigation, and post-market surveillance.
Ensure product and design requirements are properly established, qualified, and met.
Apply verification and validation knowledge to regulated products.
Develop and assess testable and measurable specifications through requirements analysis.
Participate in test method development and validation.
Maintain accurate records of testing strategies and outcomes.
Conduct Health Risk Assessments for on-market products, including defining problems and assessing impact.
Execute Risk Assessments for both on-market devices and new product development programs.
Collaborate in multifunctional teams to develop strategies that challenge medical device design and performance while creating objective evidence for quality and safety compliance.