R&D Engineer 2

Hologic, Inc.; Marlborough (MA); Hybrid; USD 78,000 - 122,000; Full time

Job summary

Hologic, Inc. in Marlborough, MA is seeking an R&D Engineer, Sustaining to drive lifecycle management of medical devices, lead design changes, verification testing, and documentation updates while ensuring performance and regulatory compliance.

The role collaborates with Quality, Regulatory, Clinical, Manufacturing, and Operations to resolve issues, implement product enhancements, and sustain released products through rigorous engineering and CAPA processes.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or related field.
• Minimum 2 years of engineering experience in medical devices or highly regulated settings.
• Experience with CAD tools (SolidWorks) and Altium Designer.
• Hands-on prototyping, 3D printing, machining, soldering, lab skills.
• Experience with design controls, CAPA, risk management, and regulatory compliance.

Responsibilities

• Support sustaining R&D activities across product lifecycle, including enhancements and obsolescence management.
• Perform root cause analyses for complex product, manufacturing and field issues with corrective actions.
• Coordinate engineering studies, verification testing and product evaluations for design changes.
• Analyze data, test results, and feedback to drive data-based decisions.
• Translate needs into engineering requirements, specifications and controlled docs.
• Prepare technical reports, risk evaluations, and recommendations for teams and management.

Skills

Root cause analysis

CAD design

Data analysis

Prototyping

Cross-functional collaboration

Problem solving

Education

Bachelor’s degree in Mechanical or Electrical Engineering

Experience in medical device industry or regulated environment

Tools

SolidWorks

Altium Designer

Job description

We are seeking a highly motivated R&D Engineer, Sustaining to support lifecycle management activities for Hologic medical devices. This role is responsible for driving product improvements, design changes, technical investigations, verification testing, documentation updates, and continuous improvement initiatives to ensure products continue to meet performance, quality, regulatory, and customer requirements throughout their lifecycle.

The ideal candidate will have experience in medical device product development and sustaining engineering, with strong skills in CAD design, data analysis, engineering testing, root cause investigation, and quality system processes. This individual will work closely with cross-functional teams including Quality, Manufacturing, Regulatory Affairs, Clinical Affairs, and Operations to resolve technical challenges, implement product enhancements, and support the ongoing reliability, compliance, and performance of released products.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned as responsibilities as reasonably required by business needs.

• Support sustaining R&D activities for Hologic products throughout the product lifecycle, including product enhancements, design changes, obsolescence management, reliability improvements, and cost optimization initiatives.
• Investigate complex product, manufacturing, and field-related issues; perform root cause analyses and recommend effective corrective and preventive engineering solutions.
• Develop, coordinate, and execute engineering studies, verification testing, and product evaluations to support design changes, issue resolution, and continuous improvement efforts.
• Analyze and interpret technical data, test results, customer feedback, and field performance metrics to drive data-based engineering decisions.
• Translate customer, clinical, manufacturing, quality, regulatory, and business needs into engineering requirements, design updates, technical specifications, and controlled documentation.
• Prepare and communicate technical reports, engineering assessments, risk evaluations, and recommendations to technical teams, management, and cross-functional stakeholders.
• Plan, manage, and document sustaining engineering projects, including scope, deliverables, schedules, risks, and resource requirements; adjust plans as priorities evolve.
• Evaluate the feasibility, reliability, and compliance impact of proposed product changes, components, tooling, fixtures, software updates, and manufacturing process improvements.
• Partner closely with Quality, Manufacturing, Regulatory Affairs, Clinical Affairs, Supply Chain, Service, Marketing, and Operations teams to ensure successful implementation of product and process changes.
• Drive cross-functional alignment, decision-making, and execution to meet project objectives, compliance requirements, and business commitments with minimal supervision.
• Interface with manufacturing operations, suppliers, contract manufacturers, and internal stakeholders to gather feedback, resolve technical concerns, and support product performance in the field.
• Support regulatory submissions, audits, complaint investigations, CAPA activities, risk management efforts, and design control requirements as needed.

Qualifications

Education

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or a related engineering field.
• Minimum of 2 years of engineering experience in the medical device industry or another highly regulated environment.
• Experience with medical device development engineering or biomedical engineering design activities.
• Experience with CAD tools, including SolidWorks, and Altium Designer.
• Hands-on prototyping and troubleshooting experience, including 3D printing, machining, soldering, and laboratory skills.
• Experience supporting released products through design changes, product improvements, root cause investigations, verification testing, and engineering change processes.
• Proven ability to analyze technical data, evaluate design and process alternatives, and develop effective solutions to complex product and manufacturing challenges.
• Experience working within medical device quality systems and design controls, including CAPA, risk management, change management, and regulatory compliance activities.
• Demonstrated success collaborating with cross-functional teams including Quality, Manufacturing, Regulatory Affairs, Clinical Affairs, and Operations to execute projects and drive business objectives.

Experience

Skills

Preferred skills

• Experience supporting capital equipment in a sustaining engineering role.
• Experience with sustaining engineering, post-market product support, or product lifecycle management within the medical device industry.
• Familiarity with FDA Quality System Regulations, and design control requirements.
• Experience supporting complaint investigations, CAPA activities, risk assessments, verification testing, and regulatory submissions.
• Experience working with electromechanical systems, disposable medical devices, or diagnostic products.
• Prior experience mentoring junior engineers or leading cross-functional technical initiatives

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.

The annualized base salary range for this role is $78,000 - $122,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

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

Marlborough, MA, United States, US, MA Employee