R&D Engineer 2

Hologic•Marlborough, MA

12h•$78,000 - $122,100

About The Position

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.

Requirements

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.

Nice To Haves

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

Responsibilities

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.