Sr. Design Assurance Engineer - Risk Management

DIRECT SALES, US; Marlboro (MA); On-site; USD 98,000 - 153,000; Full time

Job summary

Hologic, Inc. seeks an experienced professional to tackle complex problems, applying judgment to methods while ensuring quality and safety across the product lifecycle. The role emphasizes regulatory compliance, risk management, and design controls within a highly regulated medical device environment.

The candidate should have extensive knowledge of FDA QSR 820, ISO 13485, ISO 14971, and EU MDR requirements, with strong leadership and communication skills to guide cross-functional teams.

Qualifications

• Design controls applied to manufacturing and design changes.
• Risk management across the device lifecycle.
• Quality systems support for audits, CAPAs, SSEs, and post-market surveillance.
• Regulatory standards familiarity for FDA 820, ISO 13485, ISO 14971, MDR 2017/745.
• Verification and validation requirements for regulated products.

Responsibilities

• Lead critical tasks to ensure timely completion.
• Advise on risk management and product quality across lifecycles.
• Communicate assessments clearly to multi-disciplinary teams.
• Document testing strategies and outcomes accurately.

Skills

PDCA principles

Risk assessments

Verification & validation

Test method development

Communication skills

Leadership

Statistical methods

Design controls

Education

Bachelors in Engineering/Biomedical

Masters/PhD preferred

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.

• 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.

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