Sr. Design Assurance Engineer - Risk Management

Hologic, Inc.; Marlborough (MA); On-site; USD 97,600 - 152,700; Full time

Job summary

Hologic, Inc. seeks an experienced quality/regulatory professional to support medical device quality and safety throughout the product lifecycle.

You will apply judgment to resolve complex issues with limited day-to-day instruction, and collaborate on design controls, risk management and post-market activities. Responsibilities include verification and validation, test method development, health risk assessments, and cross-functional collaboration to ensure FDA 820, ISO 13485 and MDR compliance.

Qualifications

• Extensive knowledge of medical device quality systems and regulatory requirements.
• Experience with FDA 820, ISO 13485, ISO 14971 and MDR regulations is required.
• Proven ability to conduct risk management, design controls, and post-market surveillance.

Responsibilities

• Lead verification and validation activities for regulated products.
• Develop and document test methods and assess results with traceability.
• Perform Health Risk Assessments and document risk controls.
• Support internal and external audits, CAPA, SSEs and regulatory compliance.

Skills

Quality systems

Regulatory compliance

Verification & Validation

Risk management

Cross-functional collaboration

Education

Bachelor’s Degree in Engineering or related field

Master’s Degree or PhD (preferred)

Tools

Quality Management Systems (QMS)

Job description

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.

Knowledge

• 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.
• Key knowledge areas include:
• Design controls, including application of design controls for manufacturing and design changes.
• Risk management, including implementation and maintenance of risk management throughout the device product lifecycle.
• Quality systems, including support for internal and external audits, NCEs, CAPAs, SSEs, QPLs, complaint investigation, and post-market surveillance.
• Product and design requirements, ensuring requirements are properly established, qualified, and met.
• 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.
• Verification and validation requirements for regulated products.
• Requirements analysis, including development of testable and measurable specifications.
• Test method validation, root cause failure analysis, statistical methods, and design of experiments.

Skills

The role requires the ability to drive action according to Deming Cycle / PDCA principles.

Important technical and quality-related skills include:

• Applying verification and validation knowledge to regulated products.
• Developing and assessing testable and measurable specifications through requirements analysis.
• Participating in test method development and validation.
• Maintaining accurate records of testing strategies and outcomes.
• Conducting Health Risk Assessments for on-market products, including defining problems and assessing impact.
• Executing Risk Assessments for both on-market devices and new product development programs.

Communication and leadership skills include:

• 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.

Behavior

The expected behaviors include communication, active listening, collaboration, teamwork, responsibility, accountability, reliability, organization, planning, time management, problem solving, creativity, strategic thinking, analytical focus, critical thinking, flexibility, and adaptability.

The role also requires collaboration in multifunctional teams to develop strategies that challenge medical device design and performance while creating objective evidence for quality and safety compliance.

Experience

• Bachelor’s Degree, preferably in Engineering, Biomedical, or a related field
• Master’s Degree or PhD is a plus
• 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.

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 $97,600 - $152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

Agency and Third-Party Recruiter Notice

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

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