Senior Design Engineer

Hologic • Newark, NJ

11d • Onsite

About The Position

Join our innovative team at Hologic as a Senior Design Engineer, R&D , where you will lead cross-functional teams in the execution of design changes, product enhancements, and quality projects for medical device products. This position plays a vital role in ensuring product safety, compliance, and quality through technical leadership, root cause analysis, and adherence to regulatory standards. You’ll drive process and product improvements by analyzing post-market data, customer feedback, and field investigations, collaborating across departments to uphold our commitment to patient safety and customer satisfaction. This role will require 100% Onsite in Newark, DE or Marlborough, MA.

Requirements

• Bachelor’s Degree in engineering, preferably in Mechanical or Electrical
• At least 5 years’ experience, with a preference for 3 years in a medical device process and/or product development environment.
• Experience with FDA Quality Systems Regulation, especially Design Control requirements, ISO 13485, ISO 14971 (Risk Management), and Medical Devices Directive.
• Effective team leadership and project management skills.
• Strong knowledge of root cause failure analysis, statistical methods, and design of experiments.
• Competency in statistical analysis and tools (MiniTab preferred).
• Proficiency with CAD tools per engineering discipline.
• Knowledge of manufacturing processes (machining, injection molding, joining methods, rapid prototyping).
• Proficient with tolerance stack-ups, DFM, and GD&T.
• Excellent technical writing ability for protocols, reports, and risk documentation.
• Detail-oriented, action-oriented, and adept at technical learning.
• Must follow all applicable FDA regulations and ISO requirements.

Responsibilities

• Assume technical lead on cross-functional teams for design changes, product enhancements, and quality projects, including related testing, assuring product inputs are clearly identified, and design verification and validation activities are compliant.
• Manage and troubleshoot product, process, and component issues related to complaints and customer experience.
• Coordinate and lead resources to ensure strategic and quality project goals are achieved.
• Develop solutions to design, process, and quality issues using engineering principles, analysis, and empirical methods.
• Collaborate with R&D, PQE, and RA teams to maintain compliant risk management files.
• Support complaint investigations and root cause analysis for product returns, including documentation and corrective actions.
• Design and prototype fixtures, develop test methods, and execute protocols for verification/validation activities.
• Maintain accurate records and documentation per FDA and other regulatory requirements.
• Interact with internal and external customers to resolve quality issues and enhance customer experience.
• Lead technical project meetings and presentations to support decision-making.
• Prepare engineering reports, verification/validation documentation, and Design History File documentation.
• Apply risk management tools to identify, assess, and mitigate risks throughout the product lifecycle.
• Mentor and develop junior engineers; may assign tasks to engineers, technicians, and administrative staff.
• Travel to customer accounts as required.

Benefits

• We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.
• We are committed to making Hologic the company where top talent comes to grow.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees