Senior Design Engineer at 300.5761.0200 MAMMOGRAPHY - CLINICAL, US

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. 

Key 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.

Physical Demands:

• Sit; use hands to finger, handle or feel objects, tools, or controls.
• Stand; walk; reach with hands and arms; stoop, kneel, crouch, or crawl.
• Lift/move and carry products weighing up to 40 pounds.
• Exposure to moving mechanical parts, vibration, and/or moderate noise levels.
• Travel to customer accounts as required.

Qualifications:

• 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.

Skills:

• 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.

So why join Hologic?

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. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

 If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!

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, 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.

As part of our commitment to a fair and accurate evaluation of each candidate's qualifications, we require all applicants to refrain from using AI tools, such as generative AI or automated writing assistance, during any stage of the interview process. Responses influenced by AI may result in disqualification. We appreciate your understanding and cooperation in ensuring a transparent and equitable selection process.

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

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