Job Description

We are seeking an experienced Senior Design Assurance Engineer to join our dynamic team. In this role, you will leverage your expertise in design control, risk management, quality systems, and change management to ensure our medical devices are safe and effective. This role is located in Newark, DE and we are open to hybrid attendance.

If you are ready to take on a challenging and rewarding role that allows you to drive quality and innovation in the medical device industry, apply today and become an integral part of our mission to enhance healthcare and improve patient outcomes!

Essential Duties and Responsibilities:

Maintain and employ extensive integrated knowledge of assigned products to provide support assuring Medical Device Quality, Compliance and Safety along life cycle from product development to market and post-market follow-up
Ensure that safety and effectiveness are integral to the design and maintenance of our medical devices through rigorous design control, risk management, quality systems, and change management practices.
Tackle problems of diverse scope by analyzing data and evaluating identifiable factors. Demonstrate good judgment in selecting methods and techniques to obtain innovative solutions.
Collaborate and network with senior internal and external personnel within your area of expertise to drive quality initiatives forward.
Resolve a wide range of issues in creative and effective ways.
Implement and maintain Risk Management throughout the device product life cycle.
Support all activities that Design Assurance is Responsible, Accountable, and Consulted for during product development or product transfers (acquisitions) including validation, verification, and clinical preparation where applicable.

Qualifications:

Bachelor's Degree (Engineering, Biomedical or related field preferred), May have Master's Degree, May have PhD
3-5 years of experienc
Ability to drive action in accordance with Deming Cycle (PDCA) Principles
Working knowledge of verification and validation requirements for a regulated product
Working knowledge of requirements analysis, including development of testable and measurable specifications
Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution.
Ability to appropriately assess written product and project documentation as the principal advocate for compliance, and ability to effectively communicate assessment.
Strong written, verbal and technical writing communication skills. Fluent English (written and verbal).
Working knowledge of test method validation, root cause failure analysis, statistical methods, and design of experiments
Communication/Active Listening, Collaboration/Team Player, Responsibility/Accountability and Reliability, Organization/Planning/Time Management, Problem Solving/Creativity, Strategic, Analytic/Focus/Critical Thinking, Flexibility and Adaptability

Skills:

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
Prior experience in medical device or other highly regulated industry
Experienced with Good Laboratory Practices
Experienced with Usability, Reliability, Electrical Safety and Software standards and regulations.
Bilingual is beneficial.
ASQ Certified Quality Engineer is desirable.
Six Sigma Certification is desirable.

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 $94,800 to $129,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, 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.

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Senior Design Assurance Engineer