R&D Engineer II (P2)

Boston Scientific; Marlboro (MA); Hybrid; USD 75,000 - 143,000; Full time

Job summary

Boston Scientific is seeking an R&D Engineer II (P2) to support sustaining Endoscopy products. You will monitor product changes, run tests, and collaborate across teams to ensure quality and regulatory compliance throughout the lifecycle.

This role follows a hybrid work model requiring three days in-office per week in Marlborough, MA. The candidate will bring at least 3 years of engineering experience, strong data analysis, and knowledge of quality systems and design controls.

Qualifications

• Bachelor’s degree in Mechanical Engineering or Biomedical Engineering.
• Minimum of 3 years of engineering experience in product development, sustaining engineering, or a related technical role.
• Experience analyzing technical data, drawing conclusions, and making recommendations based on inputs from multiple sources.
• Strong problem-solving skills, technical judgment, and ability to work through ambiguity with a hands-on approach.
• Working knowledge of quality systems, design controls, and regulatory standards (ISO 13485 and/or 21 CFR 820).
• Ability to collaborate across functions and communicate technical information clearly to technical and non-technical audiences.

Responsibilities

• Support sustaining R&D activities for commercial Endoscopy products, including product improvements and lifecycle management.
• Investigate technical, quality, supplier, or manufacturing issues; assess root cause; evaluate design or process alternatives.
• Design, coordinate, and execute engineering tests and experiments; analyze data to support decisions.
• Assess feasibility and robustness of proposed product, material, or equipment changes.
• Prepare and review engineering documentation and regulatory submission inputs.
• Collaborate with project management, quality, regulatory, manufacturing, and other stakeholders to meet milestones.

Skills

Technical data analysis

Problem solving

Cross-functional collaboration

Education

Bachelor’s degree in Mechanical Engineering or Biomedical Engineering

Job description

Additional Location(s): US-MA-MarlboroughDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.About the role:Join our Endoscopy Sustaining R&D team, where we protect product quality, compliance and business continuity across a portfolio of commercial medical devices. Our engineers improve and optimize released products, solve complex technical challenges, and ensure Endoscopy technologies continue to meet the needs of patients, physicians, and the business throughout their lifecycle.We are seeking a dynamic and collaborative R&D Engineer II (P2) to support sustaining R&D initiatives, including product improvements, design changes, supply continuity projects, technical investigations, and lifecycle management activities. In this role, you will work in a cross-functional team to monitor product, material, process, and documentation changes; execute technical projects, and ensure commercial products continue to meet customer, patient, business, quality, and regulatory expectations.At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.Your responsibilities will include:Support sustaining R&D activities for commercial Endoscopy products, including product improvements, design changes, test method development, design verification, and lifecycle management initiatives.Investigate technical, quality, supplier, or manufacturing issues; assess root cause; evaluate design or process alternatives; and recommend sound engineering solutions.Design, coordinate, and execute engineering tests and experiments; summarize, analyze, and draw conclusions from technical data to support decisions and recommendations.Assess the feasibility, robustness, and technical soundness of proposed product, material, process, tooling, fixture, or equipment changes.Prepare and review engineering documentation, including design change assessments, test protocols, technical reports, design history file deliverables, risk documentation, and regulatory submission inputs.Work closely with project management, quality, manufacturing, process development, regulatory affairs, clinical, marketing, and other cross-functional partners to ensure successful execution of sustaining engineering projects.Plan and schedule individual and small-team activities needed to meet project milestones and business objectives with limited supervision.Present project status, technical findings, risks, and recommendations to technical and cross-functional stakeholders.Demonstrate a strong commitment to patient safety and product quality by maintaining compliance with applicable quality system and regulatory requirements.Required qualifications:Bachelor’s degree or higher in Mechanical Engineering, Biomedical Engineering, or a related technical field.Minimum of 3 years of engineering experience in product development, sustaining engineering, or a related technical role.Experience analyzing technical data, drawing conclusions, and making recommendations based on inputs from multiple sources.Strong problem-solving skills, technical judgment, and ability to work through ambiguity with a hands-on approach.Working knowledge of quality systems, design controls, and regulatory standards, including ISO 13485 and/or 21 CFR 820.Ability to collaborate effectively across functions and communicate technical information clearly to technical and non-technical audiences.Preferred qualifications:Experience working in the medical device industry, preferably in a regulated R&D or sustaining engineering environment.Experience supporting design changes, post-launch product improvements, supply continuity, complaint reduction, or product lifecycle management initiatives.Experience with test method development, design verification, design validation, risk management, and design history file documentation.Demonstrated success working within global, cross-functional teams that include quality, manufacturing, regulatory, clinical, marketing, operations, or supplier partners.Familiarity with Endoscopy devices, anatomy, therapies, or related clinical applications.Strong time management, project coordination, and communication skills with the ability to manage multiple priorities.Requisition ID: 633593Minimum Salary: $ 75100Maximum Salary: $ 142600The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.